Head of CMC Regulatory Affairs - Biologics (Remote)
Travere Therapeutics
Manchester, NH
- Remote job
Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for CMC activities across development and commercial programs. The role focuses on biologics and lifecycle management, leading global submissions and Health Authority interactions from San Diego with a strong cross-functional collaboration. The ideal candidate will have 8+ years in Regulatory Affairs with CMC expertise, strong knowledge of biologics, and #J-18808-Ljbffr Travere Therapeutics
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Head of CMC Regulatory Affairs - Biologics (Remote) in Manchester, NH vacancy
$132k - $172k
....Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...and lifecycle management activities for biologic products, with a strong focus on late-... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workFull timeTemporary workWorldwide$150k - $195k
...Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing strategic... ...lifecycle management activities for biologic products, with a strong focus on late-... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workFull timeTemporary work$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...SuggestedFull timeTemporary workLocal area$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate Director... ...leads and executes global regulatory CMC strategies across... ...products focusing on biologics. This role is... ...Pharmacy, Regulatory Affairs, or related life science... ...designated as: 1. Hybrid: work remotely up to two days per...Remote workFull timeSummer workFlexible hours2 days per week- ...Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies... ...Executive Director, Regulatory Affairs and collaborates across Tech Ops... ...CTA/IND and BLA/MAA filings for biologics, manage the CMC document control...Suggested
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical...
- Travere Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across development and commercialization. You will partner with cross-functional teams to align CMC plans with regulatory requirements...Remote job
- Meet Life Sciences is seeking a Senior Director of Regulatory CMC to lead global regulatory strategies for clinical development and commercial... ...role requires deep CMC expertise across small molecules and biologics, exceptional negotiation with authorities, and a track record...
$242k - $313.5k
...- realizing a world where people with immune‑mediated diseases can live life fully. Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior‑level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (...Local areaFlexible hours2 days per week- 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...
- Travere Therapeutics seeks an experienced Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC... ...commercial programs. You will lead global submissions for biologics, interact with Health Authorities, and guide lifecycle strategies...Remote job
$302.01k - $390.83k
...aspirations. Join Gilead and help create possible, together.Job DescriptionJOB DESCRIPTIONLead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives.Lead global CMC regulatory...Full timeFor contractorsLocal area- Travere Therapeutics in San Diego seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across development and commercialization. The role emphasizes late-stage programs and rare diseases, coordinating cross-functional teams...Remote job
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead strategic regulatory activities for biologics, supporting development through commercialization. The role collaborates with Technical Operations, Manufacturing, Quality, and Development...Remote job
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics across development and commercialization. The role leads global CMC strategies, drives submissions, and partners with Regulatory, Operations...Remote job
$148.5k - $257.4k
...provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities... ...Engineering, Analytical Sciences, Biology, or similar.10+ years of Regulatory CMC... ...InformationPosition Location: Indianapolis, IN. A remote option may be considered. Relocation...Remote workRelocation packageFlexible hours$132k - $172k
....Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...regulatory support for combination products or biologic products when applicable; prior... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workFull timeTemporary work- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle. You will collaborate with Process Development, Analytical...
$246.98k - $299.29k
....com/working-with-us.The GRS-CMC Director is responsible for overseeing... ...direction based on global regulatory guidelines and experience.... ...advanced therapies and/ or, biologic, cell therapy upstream and... ...capability centers. Employees in remote-by-design or lab-based roles...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...Client is seeking an experienced CMC Project Manager to provide... ...engagement is aligned to regulatory filing milestones, including... ...experience supporting late‑stage biologics programs Strong background in... ...preferred TRAVEL & LOCATION REMOTE. START & TERM Immediate start...Remote workContract workImmediate start
$238k - $374k
...DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a... ...and submissions for small molecule and biologic products through Phase 2 development.... ...in accordance with Takeda’s Hybrid and Remote Work policyTakeda Compensation and...Remote workMinimum wageTemporary workLocal area$207.5k - $255.2k
...development and implementation of CMC regulatory strategy for small molecule... ...As Director CMC Regulatory Affairs, you will be an essential... ...& Compensation: This role is remote-friendly, with most work conducted... ...TechBio company decoding biology to radically improve lives. Recursion...Remote workWork at officeLocal areaWork from homeWorldwide- Brief Description: The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing... ...or development projects worldwide for biological products. Essential Functions Managing... ...communication skills. #LI-SM1 #LI-remote #J-18808-Ljbffr Jazz PharmaceuticalsRemote workWorldwide
- Regulatory CMC Manager Cell and Gene Therapy Updated: Yesterday Location: Remote, DC, Colombia Job ID: 25108926-OTHLOC-7352-2DR Description Regulatory... ...Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical...Remote workContract work
- Title: Associate Director/Director, Regulatory CMC Location: North Carolina/Remote If you are interested in the below position, please send your resume... ...manufacturing, and quality control. Experience with biologics and combination products required; experience with monoclonal...Remote workContract work
$174.5k - $274.23k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...modalities—including small molecules, biologics, and external manufacturing sites—the... ...hybrid” following Takeda’s Hybrid and Remote Work policy. Takeda Compensation And Benefits...Remote workMinimum wageTemporary workLocal areaWorldwide- ...strategic, the full-time salaried Regulatory CMC Associate Director will develop... ...-functional teams while working remotely. Key responsibilities: Leads... ...a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Regulatory Affairs) Minimum 10 years of experience...Remote workFull time
Virtual Vocations Inc
United States4 days ago - Vertex Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface...
- ...Position Summary: The Senior Director, Head of Regulatory Affairs is Orca Bio's functional Head of... ...programs, new indications, global expansion, CMC Regulatory and other significant... ...related factors as permitted by law. For remote-based positions, this range may vary...Remote workFull timeLocal areaImmediate start
Orca Bio
Menlo Park, CA29 days ago - ...South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies for manufacturing products... ...role reports to the Executive Director, Regulatory Affairs and collaborates with Tech Ops leadership and...Full time
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Head of CMC Regulatory Affairs - Biologics (Remote). Be the first to apply!
Related searches
- food regulatory Manchester, NH
- regulatory engineer Manchester, NH
- regulatory Manchester, NH
- regulatory technician Manchester, NH
- regulatory law Manchester, NH
- regulatory contract Manchester, NH
- remote insurance agent Manchester, NH
- remote no experience Manchester, NH
- remote medical coding supervisor Manchester, NH
- informatica remote Manchester, NH