Manager, Global Regulatory Affairs, Oncology
$138.75k - $231.25kNational Society for Black Engineers
Global Regulatory Affairs Manager Develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. Collaborate with cross‑functional teams to shape development plans and regulatory interactions across multiple regions. Key Responsibilities Work closely with GRL, global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements. Collaborate with cross‑functional teams to align regulatory plans with Medicines Development Strategy and Integrated Asset Plan. Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval. Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision‑making. Ensure compliance with global, regional, and local regulatory requirements throughout the product life cycle. Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes. Basic Qualifications & Skills Bachelor's degree in biological or healthcare science. 1+ years experience in the drug development process within regulatory affairs, preferably oncology. 1+ years of experience in clinical trial requirements in at least one major regional/global market. Preferred Qualifications & Skills Advanced Scientific Degree (PhD, MD, PharmD). Proven ability in managing global and regional development, submission, and approval activities. Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints. Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation. Strong written and verbal communication skills for clarity and impact. Experience working effectively in matrix teams. Compensation & Benefits Annual Base Salary: For candidates based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $138,750 to $231,250. The US salary ranges account for location, skills, experience, education, and market rates. This position also offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care and other insurance benefits for employees and families, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Equal Opportunity Employer GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any other basis prohibited under federal, state, or local law. #J-18808-Ljbffr
- ...you have experience in all aspects of a Regulatory Affairs project, supporting technical/CMC,... ...maintain current licenses? As part of the Global Regulatory Affairs (GRA) team you will... ...for a challenge? If so, this Vaccines Manager of Global Regulatory Affairs role could...Suggested
$153.5k - $203.25k
...Initial Therapeutics, Inc. is seeking an International Advocacy Director to advance medicine quality initiatives on a global scale. The successful candidate will shape regulations through key organizations such as the World Health Organization and engage in strategic...Suggested- ...in-house legal advisor. This role involves overseeing legal affairs, managing external counsel, and providing strategic legal guidance on corporate... ...legal risks while supporting business growth. Remote work with required global travel is part of the position. #J-18808-LjbffrSuggestedRemote work
$182k - $346k
...areas including immunology, oncology and neuroscience - and products... ...Description The Director, Regulatory Affairs, U.S. Regulatory Policy &... ..., and interacts with senior management. Independently manages and... ...strategy that is developed by the Global Regulatory Leads and...SuggestedFull timeLocal area- ...AstraZeneca is seeking an Executive Regulatory Science Director in Gaithersburg, MD to provide global strategic regulatory expertise for oncology products. This leadership role involves mentoring regulatory leads, planning resources, and ensuring submission excellence...Suggested
- ...The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end‑to‑end planning... ...on procedural and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy...
$276k - $414k
...Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches... ...Director is a role that provides global strategic regulatory expertise and... ...regulatory environment and advise senior management on project risks/mitigation...Hourly payTemporary work- ...A clinical-stage biopharmaceutical company is looking for an experienced regulatory CMC professional to manage submissions and oversee compliance with global regulatory guidelines. The ideal candidate will have a Ph.D. and significant experience in CMC lifecycle management...
$211.58k - $317.37k
...AstraZeneca is seeking a Senior Regulatory Affairs Director to lead the global regulatory strategy for complex products. This role is crucial for securing rapid approvals in alignment with market and patient needs. The ideal candidate will have at least 10 years of regulatory...- ...candidate will have 10–15+ years of compliance experience and a strong understanding of regulatory frameworks. The CCO will oversee compliance controls, provide strategic advice to management, and foster a culture of integrity. The salary range is $170,000 – $200,000 with...
- ...Responsibilities: Provide regulatory leadership for assigned development... ...regulatory activities with global in-house/outsourced sites.... ...BLA/MAA for eCTD submissions). Manage and coordinate preparation and... ...regulatory environment for oncology, antifectives, autoimmune diseases...Full timeLocal areaNight shift
- ...across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our... ...Instagram , X and YouTube. Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge...Full timeWork at officeLocal areaRemote work
- ...our entrepreneurial roots to our current global presence, we've grown into a force for... ...Develop and execute the Global Regulatory Affairs strategy for the IVD and life sciences... ...goals to meet business objectives. Manage the annual Global Regulatory Affairs operating...Local area
- Cesna-Recruitment is seeking a Finance Manager to oversee full financial operations. This role includes managing cash flow, financial... ..., all while collaborating with external accounting firms and a global finance team. The ideal candidate should have a Bachelor's degree...
$90.3k - $165.4k
...shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career... ...services to meet deadlines, developing internal team members, and managing engagement economics. You’ll continuously build on technical competence...Work experience placementSummer holidayLocal areaFlexible hours- ...USP in Rockville, MD, seeks a Senior Manager, Talent Management to lead the development of learning strategies that strengthen organizational capabilities. The role prioritizes integrating learning into daily operations and advancing leadership capabilities. The ideal...
$116.5k
...The U.S. Pharmacopeial Convention (USP) seeks a Senior Manager, Talent Management to shape its talent strategy and drive organizational learning. This role involves designing impactful learning programs, aligning development with business strategy, and partnering with...- ...Maryland, is seeking an Executive Director/Senior Director for Regulatory Affairs to oversee IND/IMPD, BLA, and ex-US activities for CAR‑T and... ..., and strong leadership qualities. This role involves managing regulatory submissions and leading cross-functional teams. #J...
$270.22k - $405.33k
...At AstraZeneca, our Oncology ambition is unparalleled. We'... ...you will own and drive the global Oncology R&D strategy, setting... ...design, competitive dynamics, regulatory environments, and market access... ...finance experience: Background in management consulting, venture capital,...Temporary workWork at officeFlexible hours3 days per week$170k - $200k
...Program in line with SEC and other applicable regulatory requirements and ISS STOXX group... ...independence, authority, and access to senior management consistent with regulatory expectations.... ...; ability to operate effectively in a global, matrixed organization and manage...Local areaFlexible hours- ...Join AstraZeneca’s Oncology Business Unit (OBU) in a role where strategy meets scientific... ...consulting in which you have contributed to the global pipeline strategy (e.g., market... ...decisive and proactive; must be able to manage multiple priorities in a fast‑growing organization...Hourly payTemporary work
- ...Precigen is seeking an Executive Director, Regulatory Affairs, in Germantown, MD. This position oversees IND/IMPD and BLA activities for CAR... ...products. The Executive Director will lead regulatory strategies, manage cross-functional teams, and ensure timely approvals of...
$40 per hour
...corporate office in McLean, VA This is your chance to be part of a Finance Team that serves as a critical business partner managing all global activities related to financial performance, accounting, tax, forecasting, risk management, and asset management. As a Manager...Full timeWork at officeNight shift$241.61k - $362.42k
Executive Director, Strategy , Oncology R&D Location: Waltham or Gaithersburg Do you have... ...portfolio? About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company... ...interpersonal and relationship management skills with consultative approach and ability...Hourly payTemporary workWorldwide$267.91k - $401.87k
...Executive Director, Oncology Business Unit (OBU) Strategy Drive... ...strategy with Oncology R&D and global franchise partners. Engage... ...proactive; must be able to manage multiple priorities in a fast... ...Thorough understanding of regulatory and pricing dynamics in major...Temporary workWork at officeRemote workFlexible hours3 days per week- ...Director of Human Resources to shape the future of science and global health. The role emphasizes strategic HR alignment, overseeing... ...sciences and government contracting, focusing on HR strategy, change management, and workforce planning. Comprehensive benefits and competitive...
- ...AstraZeneca is seeking a Global Marketing Associate Director in Gaithersburg, MD, who will... ...engage with cross-functional teams and manage agency relationships to ensure effective... ...healthcare industry experience, especially in oncology marketing. The position offers...
- ...Auberge Collection in Bethesda, MD is seeking a Benefits Manager to oversee and enhance the administration of U.S. benefits programs, ensuring compliance and strategic oversight. This role involves managing vendor partnerships and collaborating with internal teams to improve...
$74.79k - $115.06k
...US Oncology Inc. is hiring a Laboratory Supervisor in Rockville, Maryland, responsible for the efficient operation of a moderate to high complexity lab. The role includes supervising personnel, ensuring compliance with regulations, and quality assurance in laboratory...- A leading financial services company is seeking a Manager, Process Manager for their Global Payment Network team in McLean, VA. The role involves managing product roadmaps, collaborating with stakeholders for effective decision-making, and ensuring adherence to governance...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Manager, Global Regulatory Affairs, Oncology. Be the first to apply!
- compliance director Rockville, MD
- head compliance Rockville, MD
- regulatory manager Rockville, MD
- regulatory affairs director Rockville, MD
- manager regulatory affairs Rockville, MD
- compliance manager Rockville, MD
- regulatory & compliance manager Rockville, MD
- regulatory accountant Rockville, MD
- regulatory scientist Rockville, MD
- regulatory contract Rockville, MD

