Associate Director, Biologics CMC Regulatory — Remote
Travere Therapeutics
- Remote job
Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics across development and commercial programs. You will drive global CMC strategies, author Module 2/3 content, and coordinate with Operations, Quality, and Development teams to meet regulatory requirements. The role emphasizes late-stage development, Phase 3 programs, and rare disease therapeutics with global health authority interactions and lifecycle #J-18808-Ljbffr Travere Therapeutics
$150k - $195k
...rare patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing... ...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 workRegulatoryFull timeTemporary work$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...commercial products focusing on biologics. This role is accountable for authoring... ...designated as: 1. Hybrid: work remotely up to two days per week; or...Remote workRegulatoryFull timeSummer workFlexible hours2 days per week$150k - $211k
...Role SummaryReporting to the Director of Drug Substance (Biologics), MSAT, this role is an... ...cycle management, and global regulatory submissions of complex... ...various SMEs from MSAT, QA, QC, CMC, External Manufacturing,... ..., US but will consider remote applicantsDomestic and international...Remote workRegulatoryTemporary workWorldwideFlexible hours$144.06k - $205.8k
...global leadership role in the Regulatory Affairs department for the Chemistry... ..., Manufacturing and Controls (CMC) aspects of regulatory... ...RequirementsRequired Qualifications:BS in Biology or equivalent degree10 years... ...is based in Westborough, MA. Remote work from anywhere in the US...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide$170k - $198k
...courageously make the most complex biologics ever attempted to protect... ...Analytical organization as Associate Director, CMC Statistician. The position... ...MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and... ...to work independently in a remote, matrixed, and highly...Remote workRegulatory- ...and strategic, the full-time salaried Regulatory CMC Associate Director will develop and execute multi-... ...cross-functional teams while working remotely. Key responsibilities: Leads the preparation... ...in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Regulatory...Remote workRegulatoryFull time
- ...Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance... ...Manufacturing in San Diego (hybrid remote not allowed). You will... ..., partnering with QA, Regulatory, and external CDMOs. The... ...processing, PPQ support, and CMC documentation for IND,...Remote workRegulatory
- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical... ...in biochemistry, chemistry, biology, or related pharmaceutical fields... ...a dynamic workplace that balances remote work flexibility with the benefits...Remote workRegulatoryContract work
$164k
...the Role: We're looking for an Associate Director, Regulatory Affairs CMC on the Regulatory Affairs CMC team... ...biotechnology or pharmaceutical industry. Biologics and inhalation drug product... ...Where You'll Work This is a fully remote role. It can be performed effectively...Remote workRegulatoryTemporary workLocal areaFlexible hours$170k - $220k
Associate Director, Regulatory CMC - Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision... ...Guidances pertaining to the CMC aspects of biological product development. Experience in... ...goals, including face to face and remote interactions. Excellent verbal and...Remote workRegulatoryFull timeTemporary workFlexible hours- 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...Regulatory
- TCG Labs‑Soleil is seeking a Senior Manager / Associate Director, Process Development to lead CMC biologics DS/DP process development and manufacturing efforts.... ...transfer, and cross‑functional collaboration with QA, regulatory, and external CDMOs. The role emphasizes strong...Regulatory
$150k - $195k
...Location: San Diego, USA- Remote Be a part of a global... .... Position Summary The Associate Director, Technical Operations, Biologics Drug Substance Manufacturing... ..., Quality, and Regulatory Affairs on manufacturing... ...documentation supporting CMC sections of IND, BLA, and...Remote workRegulatoryContract workTemporary work- Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for CMC activities... ...and commercial programs. The role focuses on biologics and lifecycle management, leading global submissions and...Remote jobRegulatory
- 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 jobRegulatory
- 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 jobRegulatory
- 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 jobRegulatory
- Travere Therapeutics seeks an experienced Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities... ...commercial programs. You will lead global submissions for biologics, interact with Health Authorities, and guide lifecycle...Remote jobRegulatory
$169.22k - $253k
...Associate Director of MSAT (Manufacturing Science & Technology) – Analytical Sciences The Associate... ..., and commercial manufacturing of biologic drug substances and drug products.... ...review, and approve analytical sections of regulatory filings (BLA/MAA, responses to agency...Remote workRegulatoryContract workTemporary workLocal areaFlexible hours- Travere Therapeutics in San Diego, with remote options, is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing... .... The role collaborates with Quality, Regulatory, Clinical, and Supply Chain to meet milestones...Remote jobRegulatory
$132k - $172k
...patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing... ...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 provides...Remote workRegulatoryFull timeTemporary workWorldwide$169.22k - $253k
...Remote Full time R11173 Position Summary The Associate Director of MSAT (Manufacturing Science & Technology) - Analytical... ...commercial manufacturing of biologic drug substances and drug products... ...analytical sections of regulatory filings (BLA/MAA, responses to...Remote workRegulatoryFull timeContract workTemporary workLocal areaWorldwideFlexible hours$150k - $195k
...patients.Position Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight... ...partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain... ...No role is expected to be 100% remote.Travere is an EEO/AA/Veteran/...Remote workRegulatoryFull timeContract workTemporary work$154.4k - $242.55k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...as "hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation...Remote workRegulatoryMinimum wageTemporary workLocal areaWorldwide- Travere Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing activities conducted... ...molecule drug products, partnering with Quality, Regulatory Affairs, Clinical, and Supply Chain. The ideal...Remote jobRegulatory
- Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API... ...Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone...Remote jobRegulatory
- ...WuXi CMC Program Manager This role is a central pillar in building client trust and... ...confidence. Please note that this is a remote (work from home) position within Europe,... ...client stakeholders across R&D, CMC, Quality, Regulatory, and Procurement. Establish WuXi as a...Remote workRegulatoryWork from home
- Travere Therapeutics, based in San Diego, seeks an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API... ...Travere CDMOs. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to advance late...Remote jobRegulatory
- Tonix Pharmaceuticals invites an experienced Associate Director, Regulatory Affairs to lead regulatory strategies for novel biologics and drugs in early development. You will... ...advance programs. Based in a Tonix office or remote, this role reports to the Co-Head of...Remote jobRegulatoryWork at office
- Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing in a remote/hybrid setup. The role drives technical leadership... ...Technical Operations, Quality, and Regulatory to ensure robust, compliant processes and...Remote jobRegulatory
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