Global Regulatory CMC Leader — Strategy & Submissions
Net2Source (N2S)
Net2Source (N2S) seeks a Global Regulatory CMC Manager to lead global CMC regulatory strategy and submissions across diverse modalities. The role requires collaboration with Regulatory, Clinical, Manufacturing, and Quality to ensure compliant submissions and lifecycle management. The position emphasizes cross-functional leadership, expert regulatory knowledge across FDA/EMA/ICH, and ongoing readiness for health authority interactions. Ideal for senior professionals with extensive CMC experience. #J-18808-Ljbffr Net2Source (N2S)
- ...Pharmaceuticals Inc. is seeking a Manager, Regulatory Affairs to lead regulatory activities supporting global clinical trials across all phases. You will prepare and review submissions (INDs/CTAs), help shape regulatory strategy, and interact with internal and external...Regulatory
- Rocket Pharmaceuticals, Inc. is seeking a Director, Regulatory Affairs - CMC to lead global CMC regulatory strategy for its gene therapy programs. You will... ...with internal and external stakeholders to drive submissions and ensure compliance across US, EU, and international...RegulatoryFull time
$135k - $145k
VB Spine is seeking an experienced Regulatory Affairs leader to drive global regulatory strategies for medical devices. You will mentor the RA team, manage project milestones, and oversee submissions and post-market activities to ensure compliance and timely launches....Regulatory- ...Pharma Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for clinical development programs and marketing... ...experience and strong expertise in regulatory submissions. Competitive salary and comprehensive benefits...RegulatoryRemote job
- ...in Pennsylvania is seeking a strategic Director of Regulatory Affairs to provide global regulatory leadership for the product abdakibart (... ...beyond. The role includes designing regulatory strategies, leading submission processes, and collaborating with senior regulatory...Regulatory
- Hirebridge is looking for a Regulatory Specialist to lead the development of regulatory strategies for medical devices. This role involves direct client interaction, participating... ...development and ensuring compliance with global regulations. The successful candidate will...Regulatory
- Jobtailor in the United States is seeking a senior leader to drive global Quality processes, including CAPA, deviations, change control... ...partner with cross-functional teams to align Quality strategy with regulatory expectations and operational needs across a global network...Regulatory
- Recursion is seeking a Director CMC Regulatory Affairs to lead global regulatory strategy for small molecule drugs in early to late-stage trials. You will influence US, EU, and ROW submissions, coordinate internal/external teams, and ensure marking approvals while aligning...RegulatoryRemote job
- A pet products company in New York is seeking a Director of Regulatory to lead compliance efforts and develop strategies. This pivotal role requires extensive knowledge of global regulations for CPG products, a proven leadership track record, and 10+ years of regulatory...RegulatoryFull time
$205k - $341.6k
Regeneron Pharmaceuticals, Inc. is seeking a Director for Regulatory Affairs Strategy to provide leadership on global regulatory activities for the Genetic Medicine portfolio. This role involves regulatory strategy, filings, and mentorship of regulatory staff. The ideal...Regulatory- ...Therapeutics seeks an Executive Director of Regulatory Affairs to lead global regulatory strategy for our autoimmune cell therapies from... .... You will partner with Clinical, CMC, Commercial, Market Access, and Legal to ensure submission readiness and lifecycle management,...RegulatoryRemote job
$256.07k - $336.1k
...Legend Biotech is a global biotechnology... ...Director, Global Program Leader as part of the... ...global development strategies from IND enabling... ...Clinical Development, Regulatory Affairs,... ...INDs, CTAs, BLA/MAA submissions, and lifecycle management... ..., Biometrics, CMC, Quality, Manufacturing...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$300k - $400k
...mid-sized pharmaceutical company is seeking a Senior Vice President (SVP) of Regulatory Affairs in East Brunswick, New Jersey. This executive role will lead global regulatory strategy across CMC, Clinical, and Non-Clinical programs, and requires 15+ years of regulatory...Regulatory- Pfizer seeks a Global Medical Evidence Strategy Lead for the COVID-19 vaccine franchise. You will oversee strategy for real-world evidence generation... ...safety, and lead key study teams and external partnerships to advance regulatory and public health #J-18808-Ljbffr PfizerRegulatory
- MCD Global Health is seeking a Chief Financial Officer to scale financial operations and strengthen internal controls across a growing... ...Executive Leadership Team. The CFO will ensure fiduciary and regulatory compliance and lead a seven‑person finance team. The role covers...RegulatoryRemote job
- ...a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs across US, EU and ROW.... ...documents (Module 2/3, IMPD) and decisive regulatory submissions. This role emphasizes strategic leadership, fast‑...RegulatoryRemote job
- A pharmaceutical consulting firm in New Jersey seeks a Deputy Director of Global Regulatory Strategies to oversee regulatory activities and submissions. The role requires a minimum of 10 years in the pharmaceutical industry and at least 5 years in regulatory affairs. Candidates...Regulatory
- AbbVie is seeking a Director of Regulatory Affairs to serve as the Global Regulatory Lead (GRL II), responsible for developing strategies to secure market approval for products in specific therapeutic areas. The ideal candidate will have over 7 years of regulatory experience...Regulatory
- Deputy Director of Global Regulatory Strategies—New Jersey Tanner and Associates is recruiting a Deputy Director of Global Regulatory Strategies... ...within an assigned product area. Managing regulatory submissions for U.S. and foreign regulatory bodies in support of product...Regulatory
$176k - $236k
BeiGene, Ltd. is seeking a Director, Global Regulatory Project Management, to lead oncology regulatory strategies across the drug development lifecycle. This senior role... ...project management; managing NDA/BLA/MAA submissions and driving cross‑functional integration globally...Regulatory- BeOne Medicines Ltd. seeks an Executive Director, Global Regulatory Portfolio Lead to shape and execute worldwide regulatory strategies across development programs. You will guide global submissions, lifecycle management, and Health Authority interactions while coordinating...RegulatoryWorldwide
- ...toxicology for all pipeline compounds globally. You will build and guide a high‑performing... ...science. You will own IND‑enabling strategies, collaborate with regulatory and partnerships teams, and drive high‑quality, timely submissions while maintaining #J-18808-Ljbffr...Regulatory
- ...a technology vision and strategy that aligns with the overall... ...technologies to support submission acceleration and regulatory strategy. Design and... ...of new technologies among global regulatory teams to drive... ...collaboration with the business leaders. Support the development...Regulatory
$250k
...visionary and highly influential leader for the critical new role of Non-Financial Regulatory Reporting (NFRR) Global Lead. This Managing... ...comprehensive, forward-looking strategy for the NFRR function,... ...confidence in every regulatory submission and enable superior...RegulatoryFull timeShift work$135k - $230k
Team Leader - Global Exchanges Relationship Management Location New York Business Area Data... ...to define and develop our exchange data strategy. They have a deep understanding of the market landscape and regulatory frameworks in which their exchanges operate...RegulatoryTemporary workFor contractorsWork experience placement- ...privately held spine company, is seeking a Sr. Staff Regulatory Affairs Specialist to drive global regulatory strategies for complex medical devices. This role partners... ...support development, lifecycle management, and submissions, ensuring compliant, timely product launches...RegulatoryRemote job
- Parexel is seeking a Regulatory Affairs Consultant/Senior Consultant to guide global clinical development programs through the regulatory landscape with strategy, insight, and collaboration. This highly... ...health authority engagement, submission planning, and lifecycle...Regulatory
- ...Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina... ...and leading its global regulatory function... ...global regulatory strategy, serving as the primary... ...major regulatory submissions and interactions... ...influencing clinical, CMC, and organizational...Regulatory
$205k - $250k
...Intelligence (AI) Transformation Leader is responsible for owning and... ...defines and leads the AI strategy, ensuring AI is embedded into... ...meet governance, privacy, and regulatory expectations, balancing... ...Harriman (BBH) is a premier global financial services firm, known...RegulatoryFull timeWork experience placementLocal area- LVMH Group is seeking a senior accounting leader to drive global accounting strategy, revenue recognition, and financial reporting. You will oversee accounting operations, ensure regulatory compliance, and lead a high-performing team integrated into the LVMH ecosystem....Regulatory
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