Global Regulatory Leader Oncology (IND/CTA to BLA/MAA)
Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and advancing cancer therapies that meet unmet medical needs. The Executive Director of Regulatory Affairs – Global Regulatory Leader will shape global regulatory strategy, lead IND/CTA and BLA/MAA efforts, and guide labeling and risk planning across major regions. This senior leader collaborates with clinical, safety, medical affairs and manufacturing while mentoring RA teams and ensuring #J-18808-Ljbffr Summit Therapeutics
- ...Therapeutics is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategies for oncology therapeutics from development through post-marketing. You will drive IND/CTA planning, guide BLA/MAA submissions, and partner with cross-functional teams...RegulatoryRemote job
- BeOne Medicines Ltd. seeks a Regulatory Affairs Lead to drive global regulatory strategies for oncology development programs, ensuring timely market access across... ...The role requires extensive experience in IND/CTA and NDA/MAA submissions, strong leadership, and fluency...Regulatory
- ...Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs - CMC to lead global CMC strategy for small molecule development and registration... ...submissions and lifecycle changes. Experience in IND/CTA, NDA/MAA submissions, eCTDs and post-approval changes is...Regulatory
- Scorpion Therapeutics is seeking a Senior Regulatory Affairs leader to oversee global filings and compliance for a late-stage ophthalmic biologic product... .... You will lead end-to-end submissions (BLA, MAA, INDs, CTAs) and post-approval activities, coordinating with...RegulatoryRemote job
- Summit Therapeutics Inc. is an oncology-focused biopharmaceutical company headquartered in... ...several locations. The Senior Director, Regulatory Affairs, CMC will shape regulatory... ...cycle management of Summit products across global markets. The role requires hands-on leadership...Regulatory
- About CG Oncology, Inc. Are you ready to make a difference... ...Director of Regulatory Strategy to support the... ...regulatory documents including INDs/CTA, BLAs/MAA/NDS, Meeting package,... ...to interactions with global health authorities... ...including experience with BLA/MAA submissions....RegulatoryContract workRemote workWork visaFlexible hours
- ...activities from start-up to close-out, with potential to Lead CRA on global studies. You will mentor CRAs, contribute to monitoring... ...the United Kingdom, with travel about 6-8 days per month. Strong regulatory knowledge and English proficiency are essential. #J-18808-Ljbffr...RegulatoryRemote jobWorldwide
$220k - $275k
...a biopharmaceutical oncology company with a mission... ...Summit has multiple global Phase 3 clinical studies... ...approved by any regulatory authority other than... ...submissions, including INDs, IMPDs, BLAs/MAAs, supplements, and responses... ...of IND, CTA, BLA and MAA processes. Experience...RegulatoryWork at office$154.4k - $242.55k
...strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and... ...authorities specifically related to Device submissions (i.e., IND, SRDs, IDEs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work- Regulatory Connect is partnering with an oncology biotech to appoint a Senior Director / Executive Director to lead global regulatory strategy for a new oncology medicine, with a primary focus... ...candidate has led an original NDA/BLA through approval, excels in cross-functional...RegulatoryRemote job
$250k - $350k
Global Clinical Strategy Development Director - Permanent - Remote... ...and lead late-stage oncology programmes that bring life-changing... ...experience with Phase III trials and regulatory submissions. Proven track... ...Phase III trials through BLA/NDA submissions. Oversee and...RegulatoryPermanent employmentRemote workWorldwide- Pace® Analytical Services is seeking an experienced CMC/regulatory affairs professional to lead and execute global regulatory strategies for INDs, IMPDs, CTAs and related filings. This role requires strategic advisory capabilities and the ability to influence stakeholders...Regulatory
- Scorpion Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global CMC regulatory strategies for small molecule drug... ...strong CMC expertise, and the ability to drive regulatory plans across INDs, NDAs, and #J-18808-Ljbffr Travere TherapeuticsRegulatory
- KMR Search Group is seeking a senior leader to oversee the global regulatory department, guiding a team of regulatory professionals in operations, strategy, labeling, and medical writing for both approved products and pipelines. You will lead interactions with regulatory...RegulatoryWorldwide
- ...supporting process validation, commercial readiness, and regulatory submissions. In this role, you will manage AD&QC... ...and specs, and author regulatory documents (IND/IMPD/NDA/MAA) while ensuring cGMP compliance across global operations. Periodic travel to Boston may be...RegulatoryRemote job
- ...United States to lead privacy governance, risk management, and regulatory compliance. You will partner with senior stakeholders across Business... ..., and data sharing arrangements while supporting enterprise-wide campaigns and global data use policies. #J-18808-Ljbffr BarclaysRegulatory
- Capri Holdings Limited is seeking a strategic ESG reporting and controls leader to build and scale Capri's global ESG regulatory reporting infrastructure and readiness for mandatory disclosures and external assurance. This role will establish complete, accurate, repeatable...Regulatory
- Hirebridge is looking for a Regulatory Specialist to lead the development of regulatory strategies for medical devices. This role involves... ...in business development and ensuring compliance with global regulations. The successful candidate will collaborate with diverse...Regulatory
- ...United States seeks a Senior Reward & Mobility Manager to drive the global reward and mobility agenda across jurisdictions, aligning... ...governance and audits, and lead a team through integrations, transformations and regulatory considerations. #J-18808-Ljbffr Enstar GroupRegulatory
- Jazz Pharmaceuticals is seeking a Global Study Leader to oversee global Phase I-IV trials, manage budgets and timelines, and act as an SME... ...lead trial strategies across the lifecycle while ensuring regulatory compliance and high-quality execution. #J-18808-Ljbffr Jazz...Regulatory
- ...Clinical Development in solid tumors to drive global strategy for Elecestrant across Phase I-... ...safety review, data interpretation and regulatory submissions, coordinating with Clin Ops,... ...emphasizes leadership in a fast-paced oncology environment. #J-18808-Ljbffr Menarini...RegulatoryWork at office
- ...Biosystems, a Danaher operating company, seeks a Scientific Global Product Leader for Advanced Staining Reagents to define strategy for AI-... ...lifecycle ownership, and collaborate across R&D, Clinical, Regulatory and Commercial teams. The role supports remote global activities...RegulatoryRemote work
- ...Senior Vice President, Global Regulatory Affairs About the Company Clinical-stage biotechnology... ...with a multi-asset pipeline across oncology, neuroscience, immunology, and rare... ...candidate will be the senior-most regulatory leader, responsible for developing and driving...Regulatory
- ...Senior Vice President, Group Head of Ceded Reinsurance to lead the global ceded reinsurance function and set enterprise strategy for risk... .... The role oversees treaty and facultative purchasing, regulatory compliance, and relationships with brokers and reinsurers, reporting...Regulatory
- ...VP, Global Head of Drug Safety & Pharmacovigilance Clinical-Stage Biotech | Boston/... ...Data Safety Monitoring Committees. Regulatory & Submissions Serve as SME author, reviewer... ...in regulatory submissions (DSUR, BLA/NDA, MAA), clinical study documents, labeling, Company...Regulatory
$200k - $290k
...Global Leader - Information Security Ready to turn bold ideas into real-world impact? At Genpact, we don’t just adapt to change, we lead... ...CDC operations with emerging threats, business priorities, and regulatory requirements. Drive security automation, orchestration,...RegulatoryRemote workFlexible hoursShift work- ...Pfizer is seeking a senior Commercial leader to drive global launch readiness for its oncology portfolio. The role partners with US and ICO teams, Global Medical Affairs, and Cross-Functional partners to execute integrated launch plans and ensure market readiness. Strong...
- Scorpion Therapeutics is seeking a Vice President of Medical Affairs to lead global medical strategy and build a high-performing team in oncology and genomics diagnostics. You will serve as external spokesperson and shape scientific communications across geographies. The...Remote job
$168.37k - $220.99k
...Legend Biotech is a global biotechnology company dedicated... ...Associate Director, Regulatory Affairs as part of the... ...for the submission of INDs, CTAs, and BLAs as... ...landscape in oncology, immunology and cell therapy... ...approval process in IND/CTA/BLA/MAA Broad and in-depth knowledge...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- BeOne seeks a Senior Manager, Global Regulatory Compliance & Inspection Readiness to lead regulatory compliance programs, risk assessments, and inspection readiness across the GRA function. You will partner with Quality, PV, Clinical, Regulatory Operations, and IT to ensure...Regulatory
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