Global Regulatory CMC Lead: Strategy & Submissions
Moderna Therapeutics
Moderna Therapeutics seeks a Global Regulatory CMC Lead to coordinate regulatory CMC activities across product lifecycle, develop global strategies, and guide product teams in preparing CMC/Quality agency communications and regulatory submissions. The role requires deep knowledge of global CMC regulations, CTD format, and the ability to manage multiple projects in a fast-paced environment to bring transformative medicines to patients. #J-18808-Ljbffr Moderna Therapeutics
- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC... ...product lifecycles and develop global strategies in alignment with business priorities... ...teams and prepare CMC/Quality regulatory submissions with stakeholders to drive timely...Regulatory
- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities and developing strategies for transformative medicines. The ideal candidate will have at least 8 years in the biotech space,...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC... ...product lifecycles, develop global CMC strategies, and guide product teams in preparing... ...and regulatory applications. The role leads interactions with health authorities,...Regulatory
- ...seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies. You will partner with development and manufacturing teams to shape global CMC strategies for investigational and marketed products, while...RegulatoryRemote work
- ...Medicines in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. This role reports to the... ...Affairs & Quality and will manage global regulatory submissions (IND/CTA/NDA/MAA) and interactions with health authorities...RegulatoryWorldwide
$142.5k - $256.5k
The Role The Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities... ...developing global regulatory CMC strategies and collaborating with key stakeholders... ...regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify...RegulatoryPermanent employmentWork at officeLocal areaWork from home$170k - $220k
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication...Regulatory- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...Regulatory
- ...Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for both investigational... ...reviewing CMC sections, developing global strategies, and coordinating with cross-... ...teams to ensure compliance and timely submissions. You will act as the primary CMC...Regulatory
$224.9k - $404.6k
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...Regulatory- ...Incorporated seeks a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies across a small molecule portfolio. You will guide content for submissions, engage Health Authorities, and drive digital and AI-...Regulatory
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the... ...pre-IND planning, IND/CTA submission strategy, Phase I/II/III development... ...ensuring alignment with clinical, CMC, and non-clinical development activities...RegulatoryLocal areaFlexible hours2 days per week- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
- .... is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio... .... You will develop regulatory-CMC strategies, coordinate INDs/BLAs, prepare compilations, review dossiers for submission readiness, and guide cross-functional...Regulatory
- ...an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with... ...guidelines. This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes....Regulatory
$142.5k - $256.5k
...RoleThe Associate Director, Global Regulatory, CMC will be responsible for... ...developing global regulatory CMC strategies and collaborating with key... ...strategies for global submissions (e.g. IND/CTA/BLA/MAA) and... ...have aspired to build the leading mRNA technology platform, the...RegulatoryPermanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
...Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory... ...global regulatory CMC strategies, collaborate with stakeholders... ...strategies for global submissions (IND, CTA, BLA, MAA) and identify... ...authority guidelines. Lead regulatory CMC discussions...Regulatory$180k - $245k
...and strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...and executing regulatory strategies that support global product... ...background is preferred. CMC experience is a plus.... ...expectations.Lead the preparation, submission, and maintenance of...Regulatory- ...status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare... ...the Head of Access Marketing, Strategy, & US HEOR for the Americas, this role will lead the development and implementation... ...Review Committee (Legal/Medical/Regulatory) and experience with VeevaVault...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a... ...to devise innovative regulatory strategies while coordinating with contract... ...CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-188...RegulatoryContract workWorldwide
$193k - $210k
...pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle.... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers...Regulatory- Beeline Medicines in Boston is seeking a Director of Regulatory Strategy to lead the global regulatory strategies for early-stage and pipeline programs in the immune and inflammation (I&I) therapeutic area. The role requires at least 10 years of regulatory experience,...Regulatory
- ...looking for a Senior Director of Regulatory Affairs based in Boston, MA. This role involves leading the development and implementation of the global regulatory strategy for investigational products,... ...departments in application submissions. The ideal candidate will have...Regulatory
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions,...Regulatory
- UCB is seeking a Real-World Evidence (RWE) Strategy Lead Developed Brands, Immunology to advance evidence strategies... ..., or Atlanta, GA and 5-10% travel. You will lead global RWE programs, defining evidence needs for regulatory, market access, reimbursement, and patient...Regulatory
- 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
- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities...Regulatory
$200k - $265k
...in our bold ambition to become the leading dermatology company in the world. With... ...impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement... ...clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge...RegulatoryFull timeTemporary workWork experience placementWork at officeWorldwide$224.9k - $404.6k
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...Regulatory- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled tools to enhance document quality and efficiency. This role requires 8+ years in pharma/biotech...Regulatory
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