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
- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...developing and executing regulatory strategies to support global product development, particularly in... ...health authorities such as the FDA and EMA. #J-18808-Ljbffr Monte Rosa...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
- 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
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading... ...a global perspective across FDA, EMA, and other major regulatory jurisdictions... ...regulatory strategy development for biologics and/or small molecule therapeutics,...Local areaFlexible hours2 days per week- 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...
- ...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
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets across the development lifecycle. You will drive global CMC strategy, author submissions, and coordinate with Process Development, Analytical...
- ...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$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$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- 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....
$242k - $313.5k
Senior Director, Regulatory Affairs CMC - Biologics About Beeline Medicines: Beeline Medicines is a clinical‑stage... ...biologics CMC regulatory strategies from early clinical development through... ...submitted in alignment with FDA, EMA, and global Health Authority expectations for...Local area2 days per week- ...Scholar Rock is a late-stage global biopharmaceutical company... ...leader in myostatin biology, a field focused on proteins... ...of Position: The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global... ...engagement with EMA ~ Expertise and experience...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...$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you... ...PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional, and local accountability for...Full timeTemporary workLocal area- State Street is seeking the Global Head of Regulatory Examination Management within the Global Regulatory Liaison Office to lead the firm’s global examination program, coordinating intake, scope, scheduling, responses, and closeout across jurisdictions. The role requires...Work at office
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