Global Regulatory Strategy Director (Biologics/EMA)
$200k - $300kScholar Rock
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 have at least 7 years of regulatory experience in the biopharmaceutical industry and extensive knowledge of EU requirements. The position offers a competitive salary range of $200,000 to $300,000 annually. #J-18808-Ljbffr Scholar Rock
- 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
- 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. You will coordinate cross-functional teams, negotiate with health authorities, and...Suggested
- 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...Suggested
- 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...Suggested
- ...Job Title: Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy Responsible for developing and implementing global strategies to secure and... ...Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related...
$150k
Premier Research is looking for a Regulatory Strategy, Director (Bay Area, Boston) to join our Regulatory... ...of contact and interface for FDA/EMA/national agencies on assigned projects... ...therapeutic areas and product types (drugs, biologics, drug-drug combinations, drug-device...Full time- 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
- ...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...
- 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...
- 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...
$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... ...and Experience:Bachelor's degree in biology, Chemistry, or other related...Full timeSummer workRemote workFlexible hours2 days per week$238k - $374k
...knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early... ...compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development... ...authorities, including FDA, EMA, MHRA, PMDA, and other...Minimum wageTemporary workLocal areaRemote work$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$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations... ...Are you ready to set the global regulatory vision for pioneering... ...of overall drug/biologic development processes and... ...advisory committee and/or EMA oral explanation. - Experience...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$167k - $300.7k
...The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios... ...markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing...Permanent employmentFull timeWork at officeWork from home- Biogen, Inc. is seeking a Head of Global Product Quality for Biologics to lead the PDQ team and drive strategy, governance, and quality across the portfolio. The role emphasizes regulatory alignment, audits, and continuous improvement across an international matrix. Hybrid...
$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for... ...regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologicsStrategic...Full timeSummer workRemote workFlexible hours2 days per week- Biogen in Cambridge, MA seeks a senior regulatory strategy leader to drive asset strategy and ensure GMP/GCP compliance across modalities. The role involves shaping regulatory submissions, coordinating cross-functional teams, and mentoring staff to enable agile growth....
$200k - $300k
...that have high unmet need. As a global leader in the biology of the transforming growth... ...LinkedIn. Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head... ...successful engagement with EMA Expertise and experience with...Work at officeLocal areaShift work- ...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...
$180k - $245k
...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...and executing regulatory strategies that support global product development... ...authorities, including FDA, EMA, and other major agencies.Ensure...$200k - $265k
...unparalleled, direct impact. The Opportunity Leads the global regulatory strategy, submission planning, and health authority engagement for... ...of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region...Full timeTemporary workWork experience placementWork at officeWorldwide$177k - $278.08k
...class therapies, including ADCs, complex biologics and small molecules. Our goal is to... ...patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...Oncology you will set global regulatory strategy and lead major submissions for high-...Minimum wageTemporary workLocal areaRemote workWorldwide$238k - $374k
...therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...innovative and robust regulatory strategies for medical devices and drug-device... ...and Office of Combination Products), EMA/Competent Authorities under EU MDR, MHRA...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...
- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...
- ...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...
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