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.
$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...Suggested- ...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 contact...Suggested
- Moderna is seeking aRegulatory CMC Senior Leader based in Norwood, MA to manage a team of CMC experts overseeing regulatory correspondence and submissions. You will steer product strategy across portfolio and drive regulatory activities for high-quality CMC sections. You...Suggested
$224.9k - $404.6k
...for managing a team of CMC experts that prepare... ...agency correspondence and regulatory applications. This... ...to oversee the product strategy for all the products in... ...strategies for submissions(e.g. IND/CTA/BLA/MAA)... ...been recognized as a Science Magazine Top Biopharma...SuggestedPermanent employmentFull timeWork at officeWork from home$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations... ...therapies and turn breakthrough science into real options for... ...current stage through BLA submission, ensuring an efficient... ...objectives with clinical, CMC, safety and commercial strategies...SuggestedHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating... ...global regulatory CMC strategies and collaborating with... ...strategies for global submissions (e.g. IND/CTA/BLA/MAA) and... ...have been recognized as a Science Magazine Top Biopharma...Permanent employmentFull timeWork at officeWork from home- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes....
- ...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...
$200k - $265k
...countries. We deliver an innovative, science-based portfolio of premium flagship brands... ....The OpportunityLeads the global regulatory strategy, submission planning, and health authority... ...including clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge...Full timeTemporary workWork experience placementWork at officeWorldwide$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg,... ...first-in-class cell therapies and turn science into approved medicines? Do you see... ...product labeling, and accelerate submissions across multiple indications and...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$212.85k - $354.75k
...highest probability of success. We’re uniting science, technology, and talent to get ahead of disease... ...for defining the future direction of CMC regulatory submissions and ensuring alignment between regulatory strategy, development data strategies, and global enterprise...Full timeLocal area2 days per week$186.23k - $279.35k
...DescriptionAre you passionate about science and experienced within regulatory affairs and drug development? Do... ...involved in the global regulatory strategies and support the research, development... ...business. The Regulatory Affairs Director (RAD) provides strategic and...Hourly payFull timeTemporary workWorldwide3 days per week$235k - $335k
...years. For more information about our science, pipeline and people, please visit... ...Kymera is seeking a Senior/Executive Director, AI Strategy & Applications to serve as the company... ...across Research, Clinical Development, Regulatory/CMC, and G&A to turn scientific and...$189k - $246k
Department: 107000 Regulatory Location: San Diego... ...Position Summary The Director, Regulatory Affairs Strategy is responsible for... ..., Biostatistics, CMC, Quality, Nonclinical... .... Regulatory Submissions Oversee the preparation... ...degree in Life Sciences, Pharmacy, Medicine...Temporary workLocal areaRemote workWeekend work$240k - $320k
.... We deliver an innovative, science-based portfolio of premium flagship... ...This role leads US regulatory policy and advocacy efforts... ...develops science-driven policy strategies, engages with regulatory agencies... ...FDA engagement, regulatory submissions, and Health Authority...Full timeTemporary workWork experience placementWork at officeWorldwide$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible... ...global regulatory strategies across multiple... ...document preparation, and submission execution.Key Duties... ..., Pharmaceutical Sciences, Engineering, or related...Full timeSummer workRemote workFlexible hours2 days per week$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 member... ...development of robust and accurate submissions.Develops constructive...Minimum wageTemporary workLocal areaRemote workWorldwide$182k - $275k
...responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory... ...quality CMC regulatory documents and submissions, including core dossiers, INDs,...Work at office$163.5k - $281.6k
...seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy... ...including IND/CTA, BLA/MAA, and post-approval submissions.Lead and manage the preparation, authoring...For contractorsWork at officeFlexible hours$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities... ...lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and... ...regulatory strategies for global submissions (IND, CTA, BLA, MAA) and identify...$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible... ...pre-IND planning, IND/CTA submission strategy, Phase I/II/III development... ...alignment with clinical, CMC, and non-clinical... ...Development, Non-Clinical Sciences, Bioanalytics, and Translational...Local areaFlexible hours2 days per week$238k - $374k
...to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...innovative and robust regulatory strategies for medical devices and drug-device... ...global regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$238k - $374k
...the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase...Minimum wageTemporary workLocal areaRemote work$200k - $225k
...it comes down to three things: the science, the mission, and the team. At Rapport... ...Your impact: The Associate Director/Director of Regulatory Strategy will play a pivotal role in leading... ...endpoints, safety requirements, and submission strategy. Ensure compliance...Full timeWork at officeLocal areaImmediate start$200k - $220k
...Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can... ...development, commercial strategy, and beyond.... ...‑quality CMC related submissions including INDs/CTAs or...Contract workWorldwideFlexible hours$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...Documents including for regulatory submission documents and Health Authority... ...expertise in regulatory affairs science including advanced knowledge of regulatory...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$188k - $283k
...excitement of the possibilities science may unlock and driven to... ...Role: The Senior Director, Digital & Omnichannel Strategy is a critical leadership... ...of pharmaceutical regulatory, legal, and compliance requirements... .... Privacy: Upon submission of this form I...Local areaShift workNight shift3 days per week$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ...high-quality regulatory submissions, while serving as the primary... ...Regulatory Affairs, or related life science field (advanced degree...Full timeSummer workRemote workFlexible hours2 days per week$268.2k - $402.2k
...DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory... ...and quality of regulatory submission documents and Health Authority communicationsCounsels... ...expertise in regulatory affairs science including knowledge of regulatory...Full timeSummer workLocal areaRemote workFlexible hours2 days per week- 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...
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