CMC Regulatory Science Director — Strategy & Submissions
$224.9k - $404.6kInitial Therapeutics, Inc.
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates will have a MS/PhD degree and over 10 years of experience in the pharmaceutical industry, specifically in Regulatory CMC. This position offers best-in-class healthcare coverage and competitive salary ranging from $224,900 to $404,600. #J-18808-Ljbffr Initial Therapeutics, Inc.
- Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators...Suggested
$224.9k - $404.6k
...responsible for managing a team of CMC experts that prepare and... ...related agency correspondence and regulatory applications. This position will oversee the product strategy for all the products in their... ...CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and...SuggestedPermanent employment- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...will have a Bachelor's degree in life sciences, over 10 years of regulatory...Suggested
- ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...Affairs experience, particularly with CMC requirements for Small Molecule drugs....SuggestedWork at office
- Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization of products in clinical programs. This... ...pharmaceutical industry. The Director will develop regulatory strategies, interact with health authorities such as the FDA, and...SuggestedLocal area
$186.23k - $279.35k
...Description Are you passionate about science and experienced within regulatory affairs and drug development? Do... ...involved in the global regulatory strategies and support the research,... ...business. The Regulatory Affairs Director (RAD) The Regulatory Affairs Director...Hourly payTemporary workWorldwide3 days per week- JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams... ...with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership, extensive...
- ...is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls... ...candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a BS...
- Vertex Pharmaceuticals Inc (US) is seeking an Associate Director for Preclinical Sciences to lead the integration of complex pharmaceutical... ...This role involves managing project teams, overseeing regulatory submissions, and ensuring deliverables are met within budget. The...
$137k - $215.27k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...and/or post‑approval strategies for assigned products. RA CMC... ...development of robust and accurate submissions. Develops constructive relationships...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$174.5k - $274.23k
...patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...communicate regulatory strategy to drug development,... ...evaluations and regulatory submissions (considering possible strategic... ...requirements. Apply science- and risk-based approaches...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA.... ...coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing... ...relevant experience. Strong knowledge of CMC requirements and excellent organizational...
$211.85k - $317.78k
...what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and... ...early development through global submission and approval. May serve in a dual... ...: Advanced degree in a science field and 10+ years of relevant...Hourly payTemporary workWork at officeFlexible hours3 days per week$137k - $215.27k
Takeda is seeking a Regulatory Affairs professional in Boston, MA to lead regulatory CMC initiatives for various pharmaceutical products. The role requires a minimum... ...principles. You will manage regulatory submissions and foster relationships with health authorities...$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...innovative and robust regulatory strategies for medical devices and drug‑device... ...regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$137k - $215.27k
...professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... .... Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary...$212k - $333.19k
...About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...combination product regulatory strategies, particularly pertaining... ...of global regulatory submissions (e.g., Core Dossiers,... ...with proposing science‑based, data‑driven regulatory...Full timeTemporary workLocal areaWorldwideNight shift$196.8k - $295.2k
Job Summary The Regulatory Strategy Director will be responsible for the development and implementation... ...the regulatory strategy for regulatory submission documents and Health Authority... ...technical skill in regulatory affairs science, including knowledge of regulatory frameworks...Local areaRemote workFlexible hours2 days per week$232k - $348k
Regulatory Strategy Senior Director The Senior Director of Regulatory Strategy leads the development and implementation... ...Documents, including regulatory submission documents and Health Authority... ...expertise in regulatory affairs science, advanced knowledge of regulatory...Local areaRemote workFlexible hours2 days per week3 days per week$115 - $125 per hour
Job Description The Regulatory Strategy Director will be responsible for the development and implementation... ...regulatory strategy for regulatory submission documents and Health Authority... ...technical skill in regulatory affairs science including knowledge of regulatory frameworks...Contract workLocal area- ...Psychiatric Association Inc is seeking a Senior Director, Toxicology to lead scientific and technical strategy for CNS programs. The ideal candidate will... ...managing CRO partnerships, and authoring global regulatory submissions. Candidates should have extensive experience in...
- Regulatory Strategy Senior Director page is loaded## Regulatory Strategy Senior Directorlocations: Boston,... ...Documents including for regulatory submission documents and Health Authority communications... ...expertise in regulatory affairs science including advanced knowledge of...Summer workLocal areaRemote workFlexible hours2 days per week3 days per week
- Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of regulatory strategies for complex projects... ...is based in Boston and involves overseeing regulatory submissions and communications. The successful candidate will have...
- Hemab Therapeutics is looking for a Director, Regulatory Affairs in Boston, Massachusetts. In this... ...develop innovative global regulatory strategies for rare hematological disorders,... ...position involves leading regulatory submissions and communicating with health authorities...
- A major utility company in Massachusetts is seeking a skilled regulatory leader to direct distribution regulatory strategies. Candidates should have over 12 years of regulatory experience, ideally involving direct testimony before regulatory agencies. The role also demands...Work at office
- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic... ...developing and executing regulatory strategies to support global product development... ...and the ability to manage regulatory submissions and work with health authorities such...
$196.8k - $295.2k
General Summary The Regulatory Strategy Director will develop and implement global/regional regulatory... ...strategy. Shape regulatory strategy for submission documents and Health Authority... ...interactions. Advanced regulatory affairs science knowledge, including global/regional/...Local area- JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience. This... ...developing innovative global regulatory strategies and leading Global Regulatory Teams.... ...essential, as you will manage FDA submissions and collaborate with global teams to...
- ...Reporting to the Head of Regulatory Affairs, you will work... .... As the Regulatory CMC lead for these... ...innovative Regulatory strategies where little precedent... ...accomplishments:Associate Director:12+ Years of relevant... ...eCTD requirements for submission to US and ex-US regulatory...Contract workRemote work
$154.4k - $242.55k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...and/or post-approval strategies for assigned products. RA CMC... ...development of robust and accurate submissions. Develops constructive relationships...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide
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