Executive Director, Global Regulatory Affairs jobs

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Senior Director - Global Regulatory Affairs - Global Regulatory Lead,

Job Openings Senior Director - Global Regulatory Affairs - Global Regulatory Lead, About the job Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Job Title: Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Job Location: Indianapolis, Indiana, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies— from portfolio entry through end of life. You will build and lead the Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.Key ResponsibilitiesRegulatory StrategyDevelop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycleIntegrate competitive intelligence, health authority guidance, and product-specific regulatory advice to drive robust, forward-looking strategiesLead regulatory representation on the GBD/global program team, shaping development plans and providing solutions to regulatory barriersEnsure local affiliate regulatory plans align to global strategy and business priorities — spanning labeling, risk management, and issues managementUS FDA OversightOversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAsDrive high-quality communications with FDA that clearly articulate Lilly's scientific positionBuild and leverage productive relationships with FDA to support product registration goalsTeam LeadershipLead a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global LabelingFoster a culture of transparent communication, feedback, and continuous developmentCommunicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings.Represent GRA at stakeholder and governance meetings; mentor GRA personnel and may manage direct reportsExternal EngagementShape the external regulatory environment by building strategic relationships with key external stakeholdersPartner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review press/IR materialsMinimum QualificationsAdvanced scientific degree (i.e. PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug developmentORBachelor’s or Masters and 10+ years of experience in regulatory affairs and/or drug developmentAdditional PreferencesDeep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development processDemonstrated experience with regulatory submissions and agency interactions across US, EU, China, and JapanDirect experience in both clinical and CMC regulatory sciencesStrong leadership, negotiation, and stakeholder communication skills — including executive-level audiencesProven ability to assess and manage risk in a highly regulated environmentExperience in the applicable therapeutic areaThis position is based in Indianapolis, IN and relocation is provided, remote is not available for this role.Additional InformationTravel expected: 10–15%Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is$169,500 - $248,600Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.#WeAreLillyThis job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemoteSenior$169.5K–248.6K

posted 13 days ago

AstraZeneca

Executive Director, Promotional Regulatory Affairs

US - Wilmington - DEfull timeExecutive

posted 6 days ago

Merck

Associate Director, Global Regulatory Affairs

Billerica, Massachusetts, United States

posted 21 days ago

Lifelancer | Career Page

Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

Job Openings Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology About the job Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology Job Title: Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology Job Location: Washington D.C., District of Columbia, United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Join Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Director, Regulatory Affairs - Global Regulatory Leader – OncologyWhat you will doLet’s do this. Let’s change the world. Amgen is seeking a Senior Director, Regulatory Affairs supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this vital, product-facing role you will lead one or more the Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is:To lead GRTs within Amgen’s GRAAS organizationTo independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactionsTo provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applicationsKey Responsibilities include:Develop and execute global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programsLead GRTsRepresent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectivesIndependently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risksProvide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedentIndependently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changesAssess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategyClearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understoodLead GRTs and product teams in formal and informal communications with regulatory agenciesLead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategyRepresent Amgen Regulatory on external partnership teams at the product levelLead regulatory process improvements and initiativesWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree and 5 years of regulatory experience in biotech or scienceORMaster’s degree and 9 years of regulatory experience in biotech or scienceORBachelor’s degree and 11 years regulatory experience in biotech or scienceIn addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced abovePreferred Qualifications:Contemporary oncology experience desiredDemonstrated ability to lead regulatory aspects of highly complex programs in late developmentPrevious experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental applicationAbility to lead and build effective teamsStrong communication skills - both oral and writtenAbility to understand and communicate scientific/clinical informationAbility to anticipate and mitigate against future strategic issues and uncertaintiesAbility to resolve conflicts and develop a course of actionCultural awareness and sensitivity to achieve global resultsPlanning and organizing abilitiesAble to prioritize and manage multiple activitiesAbility to make complex decisions and solve problemsAbility to deal with ambiguityOrganizational savvyNegotiation skillsWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.SponsorshipSponsorship for this role is not guaranteed.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemoteSenior

posted 16 days ago

AstraZeneca

Executive Director, Regulatory Affairs Strategy - Cell Therapy

Spain - Barcelona / Netherlands - Amsterdam - Medical Business Centrefull timeExecutive

verified Aug 3, 2026posted 2 months ago

Recursion

Director, Regulatory Affairs

New York City, United StatesDirector$228.3K–280.7K

posted last month

AstraZeneca

Executive Director, Regulatory Affairs Strategy - Cell Therapy

US - Gaithersburg - MD / US - Boston - MA / US - Santa Maria - CA / US - San Francisco - CAfull timeExecutive$276K–414K

posted last month

Johnson & Johnson

Director Regulatory Affairs

Raynham, Massachusetts, United States of America / West Chester, Pennsylvania, United States of America / Palm Beach Gardens, Florida, United States of America / Warsaw, Polandfull timeDirector

verified Aug 9, 2026posted last month

Legend Biotech US

Director, Regulatory Affairs

Somerset, New Jersey, United StatesDirector$168.4K–221K

posted 6 days ago

Lifelancer | Career Page

Senior Director, Global Regulatory Affairs – Biotech Unit

Job Openings Senior Director, Global Regulatory Affairs – Biotech Unit About the job Senior Director, Global Regulatory Affairs – Biotech Unit Job Title: Senior Director, Global Regulatory Affairs – Biotech Unit Job Location: Remote (US) Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:At BeOne, our Global Development SuperHighway — our integrated, end-to-end, wholly internal development capability — is a cornerstone of our R&D vision. It brings together a unique set of internal cross-functional capabilities from across the globe needed for efficient delivery of clinical trials to develop impactful medicines to accelerate access to innovation for patients around the world.We are now opening this same delivery engine to the world’s most promising external science. Through SuperHighway partnerships, highly promising assets from leading biotech partners can access our development capabilities creating a true win-win ecosystem with the ultimate goal of helping more patients around the world. This is not a fee-for-service model; it is a bold new way to grow the company and expand what’s possible in oncology. This is a rare opportunity to help build something genuinely new — joining a high-caliber, agile team at the leading edge of clinical development innovation. If you are energized by building, by challenging the status quo, and by making a real impact on patients’ lives, this is where you belong. The position contributes to the overall partnership program strategy and driving its vision and mission. Leveraging deep therapeutic and functional area expertise, the Regulatory Affairs Lead is accountable for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for products in line with the partnership program’s goals, and in coordination with key Advisory Committee and Execution Unit. The Lead manages all regulatory aspects of allocated assets through all phases of development, post-approval, and lifecycle of the product. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met.This role helps deliver the partnership studies that run on our Clinical SuperHighway, supporting seamless onboarding and high-quality execution of external partner projects in close partnership with the execution functions.Essential Functions of the Job:Accountable for providing high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in multiple countries, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.Use extensive knowledge of US, China, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to allocated assets.Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.Review sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.Maintain awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation.Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.Manages critical issues, taking leadership for the regulatory contribution.Responsible for assisting with the development and implementation of regulatory processes.Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriate.Provide guidance to Execution Unit at regional and global level and ensure timely, quality, and efficient study planning and execution of associated clinical studies.Conduct regular review meetings with Execution Unit to mentor, support, and ensure all studies are tracking to quality and timeline.Report on study status, goals, operational KPIs, and enforce quality KPIs.Champions a global mindset and approach across GRA to foster collaboration and consistency across the organization.Participate company-wise standard discussion, finalization, and implementation.Other duties as assigned.Supervisory Responsibilities: N/A (individual contributor role; no direct reports).Education Required:Bachelor’s degree required; advanced degree preferred. A minimum of 12 years in the biotechnology or pharmaceutical industry and a minimum of 5 years in a regulatory leadership capacity with a broad background in oncology.Computer Skills: Skilled in Microsoft Office Suite Other Qualifications:Experience of working as a lead in Regulatory Affairs across two or more major geographic areas, and experience of leading multiple FDA interactions for oncology products leading to Agency approval actions.Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas.Thorough understanding of drug development process, the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing, and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges and the ability to balance short-term needs with long-term vision.Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization.Fluent in written and verbal English. Desirable: knowledge of Mandarin. Travel: Up to 20%. Ability to travel domestically and internationally.Global CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range: $211,200.00 - $281,200.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemoteSenior$281.2K

posted 6 days ago

Johnson & Johnson