Global Submissions Lead: Regulatory Strategy & Delivery
Sanofi
Sanofi is seeking a Global Submission Lead in Cambridge, MA to oversee worldwide regulatory submissions in support of new product development. You will engage deeply with cross-functional teams and external partners to ensure compliance and operational effectiveness in regulatory processes. This role demands a strong background in regulatory affairs with over 5 years of experience, alongside leadership skills and a passion for driving impactful drug development. #J-18808-Ljbffr Sanofi
$153.6k - $241.34k
A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers opportunities for strategic leadership across multiple projects. Located in Boston...Regulatory$122.25k - $176.58k
...Job title: Global Submission Lead ~ Location: Morristown, NJ / Cambridge... ...coordination, and tracking of regulatory Priority portfolio and... ...ensuring seamless execution and delivery of high-quality regulatory... ...of e-Submission strategies between two companies. Ensure...RegulatoryWorldwideFlexible hours- ...Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston,... ...with proficiency in eCTD submissions and vendor oversight. The candidate... ..., maintain compliance with global standards, and prepare... ...position offers an opportunity to lead cross-functional teams and contribute...Regulatory
- A leading biopharmaceutical company is seeking an Associate Director for Global Regulatory Affairs in Boston. This role involves leading regulatory strategies for complex projects, ensuring compliance with global regulations, and serving as the primary FDA contact. The...Regulatory
$211.5k - $258.5k
...on developing and delivering category-leading precision therapies to transform the... ...fully. Job Summary: The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing... ...pre-IND planning, IND/CTA submission strategy, Phase I/II/III development...RegulatoryLocal areaFlexible hours2 days per week- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in... ...candidate will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Regulatory
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...RegulatoryFlexible hours$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Regulatory- Allergan is seeking a Senior Director Regulatory Affairs Therapeutic Area Head in Cambridge, MA. This leadership role involves managing global regulatory strategies and supervising a team of global regulatory leads. Applicants should have over 10 years of experience in...Regulatory
- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs,...Regulatory
- ...an Associate Director, Clinical Operations (Clinical Trial Lead) to oversee global clinical studies in Boston. The role involves managing... ...operations, partnering with CROs, and ensuring compliance with regulatory requirements. Ideal candidates will have over 8 years of...Regulatory
- ...company is seeking a Senior Manager in Regulatory Affairs based in Boston. The ideal candidate will develop and execute global regulatory strategies for innovative therapeutics in... ...management skills, with a focus on leading submissions and interactions with health authorities...Regulatory
$128k - $156k
Disc Medicine in Watertown, MA, is seeking a Regulatory Operations Manager to manage regulatory submissions and document compliance activities. This full-time role requires 5-7 years of direct experience and expertise in MS Word and Veeva RIM. Responsibilities include...RegulatoryRemote jobFull time$109.1k - $135k
Philips International seeks a Senior Regulatory Affairs Specialist in Cambridge, MA to support regulatory... ...Industry. The role includes developing regulatory strategies and preparing submissions for regulatory bodies globally. The compensation is competitive, ranging from...Regulatory$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure... ...background in regulatory submissions. The position is based in...Regulatory$137k - $215.27k
...looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory... .... Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary...Regulatory$177k - $278.08k
...Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for... ...success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work- ...Therapeutics, Inc. is seeking a seasoned regulatory leader to develop and execute global regulatory strategy for its oncology portfolio. The role requires... .... Key responsibilities include leading regulatory submissions and health authority interactions, anticipating...Regulatory
$177k - $278.08k
...patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...Lead Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs. How you will...RegulatoryMinimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide- A leading biopharmaceutical company in Cambridge seeks a Senior Director of Global Regulatory Strategy in Oncology. This role involves shaping regulatory pathways for novel therapeutics, leading high-stakes health authority interactions, and developing high-performing...Regulatory
$212k - $333.19k
...worldwide.Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of... ...challenges and ideas into actionable strategies. You will set global regulatory... ...timely manner.Accountable for US FDA submissions and approvals of project(s) of...RegulatoryMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$238k - $374k
...looking for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination... ...a proven track record in managing submissions and aligning cross-functional teams....Regulatory$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development... ...over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...Regulatory$200k - $260k
A leading consulting firm in health strategy seeks a Senior Director of Regulatory Strategy Consulting in Boston. In this role, you will... ...regulatory experience to shape global strategies and lead cross-... ...managing complex regulatory submissions. The targeted compensation ranges...RegulatoryFlexible hours- Takeda seeks an Associate Director, Global Labeling Lead to manage the development of labeling content for various products. This role demands... ...management skills and extensive knowledge of US and EU regulatory requirements. Candidates should have over 8 years in the pharmaceutical...RegulatoryFull timeRemote work
$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge... ...the creation and delivery of clinical documents across... ...drug development and global regulatory submissions, ensuring quality and compliance... ..., ensuring document strategy aligns with clinical, regulatory...RegulatoryWorldwide- ...Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible... ...-Functional Teams ~ Leads Labeling cross-functional... ...Labeling Documents Authoring, Submission, and Labeling Negotiations... ...to consistently drive the delivery of team goals fostering...RegulatoryLocal areaImmediate startWorldwide
$196.7k - $353.4k
...Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology... ...Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence... ...or professional certification Delivery of at least one major application...RegulatoryPermanent employment$153.6k - $241.34k
...Associate Director, Global Labeling Lead where you will be responsible... ...content and strategy of multiple assigned... ...Authoring, Submission, and Labeling Negotiations... ...processes conform to regulatory requirements. Management... ..., timely delivery, and adherence to quality...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities....RegulatoryRemote work
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