Global Regulatory Strategy Director, Oncology (mRNA)
Moderna Therapeutics
Moderna, Inc. seeks a Director of Regulatory Strategy to drive regulatory plans for select programs within rare, autoimmune, and oncology portfolios. The role is a strategic leadership position within Global Regulatory Science, shaping submissions and advising on regulatory risks and opportunities for US and international markets. The ideal candidate has 10+ years in pharma with 8+ years in regulatory strategy, deep FDA/EU/ICH knowledge, and a track record in major approvals. #J-18808-Ljbffr Moderna Therapeutics
- Moderna, Inc. seeks a Director of Regulatory Strategy to lead global regulatory programs across rare, autoimmune and oncology portfolios, shaping plans for US and international markets... ...submissions while monitoring developments in mRNA regulation. This role requires strategic...Suggested
- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...Suggested
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...Suggested
$167k - $300.7k
...Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs... ...within the rare, autoimmune and oncology portfolios. This is a newly... ...a strategic leader within Global Regulatory Science,... ...regulatory developments related to mRNA platform and advises...SuggestedPermanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
...an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways... ...founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine...SuggestedPermanent employmentFull timeWork at officeWork from home- GlaxoSmithKline in the United States seeks a Senior Director, Global Regulatory Strategy - Oncology to lead regulatory strategies for asset development and lifecycle plans. The role collaborates with Early Development, Clinical, Safety, and Commercial teams to shape submissions...
- ...Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of Moderna’s... ...technology in the US and other global markets. Responsibilities... ...has aspired to build the leading mRNA technology platform, support...
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- ...several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and... ...LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing...Temporary workWorldwide
- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role entails developing and implementing global strategies for product approvals while leading the Global Regulatory Product Team (GRPT). The ideal candidate will possess...
- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive... ...in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and leadership...
- ...Moderna seeks a Global Medical Director to lead medical affairs across our Oncology portfolio, spanning early development to commercialization... ...alignment to advance mRNA oncology programs. As a key... ...leadership, interfacing with regulatory, clinical, and commercial partners...
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AG
- Stoke Therapeutics is seeking a Director, Global Regulatory Strategy to lead regulatory planning across Stoke's portfolio, ensuring alignment with corporate strategy and health authority requirements. You will partner with cross-functional teams and report to the Exec...
$177k - $278.08k
..., we are advancing a rapidly growing oncology portfolio with potentially first-in-class... ...patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...you will set global regulatory strategy and lead major submissions for high-impact...Minimum wageTemporary workLocal areaRemote workWorldwide$186.23k - $279.35k
...about science and experienced within regulatory affairs and drug development? Do you... ...affairs to get involved in the global regulatory strategies and support the research, development... ...the business. The Regulatory Affairs Director (RAD) provides strategic and operational...Hourly payFull timeTemporary workWorldwide3 days per week$212k - $333.19k
...through life-changing work. Certified as a Global Top Employer, we offer stimulating... ...Future to people around the world.Takeda Oncology is seeking a highly motivated, insightful... ...understanding that acts as a catalyst behind strategy, portfolio decisions, launch, and...Minimum wageTemporary workLocal areaImmediate startRemote work- A global biopharmaceutical company is seeking a Medical Director to provide leadership in lung cancer medical affairs. This position... ...involves developing medical strategies and collaborating with... ...Medical Affairs, particularly in oncology. Strong communication and relationship...
- ...experienced labeling professional to join our labeling strategy team. This team is responsible for developing... ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development...Local area
- Akebia Therapeutics seeks a Director, Regulatory Affairs - Labeling to shape global labeling strategy across our portfolio. You will serve as the enterprise expert on labeling, partnering with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC to ensure robust...
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
$168k - $252k
Job DescriptionGeneral Summary:The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in...Full timeSummer workRemote workFlexible hours2 days per week$177k - $278.08k
...inspire you and empower you to shine? Join us as a Director, Global Program Management - Clinical Oncology in our Cambridge office.At Takeda, we are transforming... ...the integrated Global Product Team (GPT) asset strategy into an efficiently executable plan; predicting and...Minimum wageTemporary workWork at officeLocal areaRemote work$212k - $333.19k
...you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office... ...(s). The GPL defines the asset strategy and leads all development and LCM... ...leadersCommitted to simultaneously driving regulatory approval as well as launch and...Minimum wageTemporary workWork at officeLocal areaRemote workNight shift- AbbVie in Boston seeks a Director, Health Economics & Outcomes Research (HEOR) to lead the development and execution of HEOR strategies for at least one asset or indication in US and/or international... ..., with strong leadership and global collaboration experience in the #J-1...
- ...SimpliSafe in Boston is seeking a Director of Tax to lead our global tax strategy, compliance, and planning, partnering with Finance, Legal, and Operations to scale growth while maintaining strong governance. The ideal candidate has 10+ years of progressive tax experience...
- ...Alexion Pharma Spain S.L. seeks a Global Safety Program Lead, Senior Director responsible for the safety strategy, delivery, and oversight of assets. You will lead safety... ...high-quality safety content, and drive regulatory interactions globally. You will manage Safety...
- ...AstraZeneca GmbH is seeking a Global Safety Program Lead, Senior Director to drive safety strategy and execution for assigned assets. You will lead safety physicians and scientists, deputise for the Global Safety Head when needed, and ensure compliance with GxP and AZ...
- Pfizer is seeking a Global Medical Evidence Strategy Lead for the COVID-19 vaccine franchise. The role focuses on epidemiologic methods, real-world evidence, and rigorous study design to support regulatory submissions and public health needs. Responsibilities include leading...
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