Director, Biologics CMC Writing & Regulatory Strategy (Remote)
Travere Therapeutics
Travere Therapeutics in San Diego, CA is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead CMC documentation for regulatory submissions. The role emphasizes drafting Module 3 sections, writing drug substance/product manufacturing content, and coordinating cross-functional teams to ensure regulator-ready narratives. The ideal candidate has deep experience with biologics, microbial systems, and device-related components, plus strong PowerPoint and regulatory #J-18808-Ljbffr
- ...Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. You... ..., manufacturing, and control strategy. The role requires extensive...Remote workRegulatory
- ...located in San Diego with remote flexibility, seeks a Director of Technical Operations (Biologics CMC Technical Writing). You will lead the preparation... ...of CTD Module 2/3 for regulatory submissions, coordinating... .... This senior role drives strategy, content standards, and timely...Remote workRegulatory
- ...Scorpion Therapeutics seeks a Director of Biologics CMC Technical Writing to lead the creation of... ...documentation for regulatory submissions such as BLA.... ...narratives, develop document strategies, and guide cross-... ...reviews and approvals while remote work with roughly 10%...Remote workRegulatory
- ...company focused on rare diseases, seeks a Director, Technical Operations (Biologics CMC Technical Writing) in San Diego with extensive CTD Module 2... .... The role leads CMC submission strategy, collaborates with Regulatory Affairs and SMEs, and directs preparation...Remote workRegulatory
- ...Scorpion Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead regulatory writing for biologics. You will develop submission strategies, author Module 3 content,... ...external partners. Remote role with some onsite requirements...Remote workRegulatory
$189 per hour
...positions listed as San Diego/Remote, our preference is for... ....Position Summary:The Director, Technical Operations (Biologics CMC Technical Writing) is responsible for... ...) documentation for regulatory submissions, including... ...of the CMC submission strategy in collaboration with...Remote workRegulatoryContract workWork experience placementWork at officeLocal area2 days per week- Director of Technical Operations (Biologics CMC Technical Writing) Responsibilities: develop and execute CMC submission strategies author and coordinate Module 3 content covering... ...changes ensure regulatory compliance and... ...travel (~10%) Location: Remote (San Diego-based, with...Remote workRegulatory
- ...Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and 3 content for regulatory submissions, including BLA. The role requires strong scientific judgment, superb writing, and collaboration...Remote workRegulatory
- Travere Therapeutics seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. The role oversees content integration, timelines, and regulatory messaging across multiple...Remote jobRegulatory
- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary Reporting to the Head of CMC, the... ...development, quality, regulatory CMC, and external manufacturing.... ...Develop and execute integrated CMC strategies aligned with overall program objectives...Remote workRegulatoryFull time
- ...Parexel is seeking a CMC Strategy Senior Associate / Consultant to lead and contribute to regulatory strategies for biologics and vaccines, spanning US, EU, and beyond. You will author... ...timely submissions. This role offers remote work with global exposure. #J-18808-...Remote workRegulatory
$160k - $274k
...Title - Senior Director, Mid-Atlantic CMC Work Location - United States (Remote) Summary: Opportunity... ...promoting WuXi Biologic’s services at... ...manufacturing strategy. Lead CMC projects... ...and meeting the regulatory requirements and... ...Experience in writing regulatory documents...Remote workRegulatoryWork from homeFlexible hours- ...Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA.... ...history, manufacturing, and control strategies. The ideal candidate has 10+...Remote workRegulatory
- ...process. Associate Director, Manufacturing... ...Manufacturing, and Controls (CMC) project... ..., Quality, Regulatory Affairs, Clinical... ...understanding of biologics manufacturing and... ...recommending mitigation strategies. Lead risk identification... ...the office, and remote employees are...Remote workRegulatoryFull timeContract workWork at officeLocal area
$203k - $228k
...Jobs Associate Director, Manufacturing... ...Business Operations & Strategy Associate... ...LOCATION: Remote (WA or MA preferred... ..., Quality, Regulatory, Finance, Legal... ...understanding of biologics or cell therapy... ...supporting CMC sections of regulatory... ...technical writing and document review...Remote workRegulatoryContract workWork at officeDay shift$150k - $210k
...our expertise in muscle biology and small molecule... ...position will contribute regulatory CMC experience to Edgewise... ...Contributes to the writing, editing, reviewing and... ...the overall regulatory strategies. May oversee external... ...working in a remote environment. ~ Able...Remote workRegulatoryFull timeFor contractors- ...someone to own CMC for it end to end... ...This is a director-level role: hands... ...analytical and release strategy, including the... ...12 years in biologics CMC. At... ...CDMOs, including writing the RFP and... ...QC, and enough regulatory fluency to defend... ...program today. Remote is fine and we...Remote workRegulatoryPermanent employmentFull timeContract workInterim role
- Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. You will guide the strategy in collaboration with Regulatory Affairs and SMEs, directing...Regulatory
$181.16k - $224.72k
Associate Director, CMC Regulatory Affairs Job Category : Development... ...onsite, hybrid and remote work environments a... ...CMC regulatory strategies for commercial compounds... ...regulatory writing skills Ability to work... ...discipline (e.g., chemistry, biological sciences,...Remote workRegulatoryFull time- ## Associate Director, Regulatory Affairs CMCApplyremote... ...the Regulatory CMC lead for these programs... ...Regulatory strategies where little precedent... ..., chemistry, biology, or related pharmaceutical... ...verbally and in writing, and superb... ...that balances remote work flexibility...Remote workRegulatoryContract work
- ...Description Leads global regulatory dossier preparation activities for novel biologics by coordinating cross-... ...preparation of CMC regulatory submission documents... ...the CMC submission strategy is aligned closely with... ...Excellent scientific writing skills including contributions...RegulatoryLocal area
$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ...products focusing on biologics. This role is accountable for... ...designated as: 1. Hybrid: work remotely up to two days per week; or select...Remote workRegulatoryFull timeSummer workFlexible hours2 days per week- ...Role We are seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory... ...join our team in a remote capacity. As a... ...Controls (CMC) regulatory strategy, compliance... ...regulatory departments Write and review submission... ...variations Previous biologics regulatory CMC experience...Remote workRegulatoryWorldwideFlexible hours
- ...Job Title: Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) Department... ...of Regulatory Location: Remote or Onsite Position... ...regulatory strategy for biologics or gene therapies and the... ...biologics. Excellent regulatory writing and communication skills....Remote workRegulatory
- ...Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. This role collaborates across Regulatory Affairs, QA, Manufacturing...Regulatory
$185k - $256k
...offer a dynamic, remote-friendly environment... ...leader and SME in CMC Chemistry,... ...to own the market strategy for it. This... ...and Quality, and Regulatory CMC Build positioning... ...Orchestration, and Biologics Support strategic... ...case, excellent writing and presentation...Remote workRegulatoryFull timeWork experience placementImmediate startFlexible hours- ...Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting Date:... ...Work Schedule: Full time Remote Work: In office Job: RI -... ...the global regulatory CMC strategy for product development and... ...from relevant partners to write regulatory CMC documents...Remote workRegulatoryPermanent employmentFull timeTemporary workWork at office
- ...Description Leads global regulatory dossier preparation activities... ...ensure consistent preparation of CMC regulatory submission... ...ensuring that the CMC submission strategy is aligned closely with the clinical... .... ~ Excellent scientific writing skills including...RegulatoryLocal area
$211.41k - $286.02k
...a Scientific Director, Product Stewardship... ...safety and regulatory compliance... ...hybrid, option for remote work may be... ...mature toxicology strategies supporting... ...Product Quality & CMC ToxicologyLead... ...ISO 10993 biological evaluations.Lead... ...scientific writing, technical communication...Remote workRegulatoryFull timeFlexible hours- ...developing next-generation biologic therapeutics for chronic respiratory... ...shaping Ailux's scientific strategy, portfolio direction, and... ..., Translational Sciences, CMC, Toxicology, Regulatory, and Clinical Development... ...diseases. Location: USA, Remote. This role requires...Remote workRegulatoryFull timeWorldwide
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