Remote-First Director, CMC Regulatory Affairs - Small Molecules
BioSpace
- Remote job
Recursion is seeking a Director of CMC Regulatory Affairs to lead global regulatory strategy for small molecule programs in early and late stages. This remote-friendly role involves coordinating across US, EU and ROW teams to drive high-quality submissions and regulatory decisions. You will manage internal and external contributors, review Module 2/3 documents, and advise on risk mitigation and compliance. Occasional travel to Salt Lake City or other offices may be required. #J-18808-Ljbffr BioSpace
$148.5k - $257.4k
...our work, and we put people first. We’re looking for people who... ..., tactical and operational regulatory CMC leadership across therapeutic... ...expedite development of the small molecule portfolio and to support... ...Location: Indianapolis, IN. A remote option may be considered. Relocation...Remote workRelocation packageFlexible hours- ...Vertex Pharmaceuticals seeks a Regulatory CMC Manager to lead detailed planning and execution of multi-product programs in international... ...ideal candidate has a life sciences degree and about five years in pharma, with Small Molecule experience and strong #J-18808-Ljbffr...Remote work
$302.01k - $390.83k
...DescriptionJOB DESCRIPTIONLead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the... ...strategies to ensure right first-time approvals of product... ...and cultural evolution of the Small Molecules organization while promoting...SuggestedFull timeFor contractorsLocal area$242k - $313.5k
...diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly... ...can live life fully. Job Summary: The Senior Director, Regulatory Affairs CMC – Small Molecules provides senior-level scientific and strategic regulatory...SuggestedFull timeLocal areaFlexible hours2 days per week$238k - $374k
...Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...strategies and submissions for small molecule and biologic products... ..., enable right-first-time submissions, and improve... ...with Takeda’s Hybrid and Remote Work policyTakeda Compensation...Remote workMinimum wageTemporary workLocal area- ..., a clinical-stage biopharmaceutical company, is seeking a Director of Regulatory Affairs CMC reporting to the VP of Regulatory Affairs to lead global CMC regulatory strategies for clinical-stage small molecule programs. This role partners with CMC, Technical Operations...
- ...company in South San Francisco seeks a Director of Regulatory CMC. This pivotal role involves... ...regulatory strategies for a pipeline of small molecules and monoclonal antibodies, ensuring... ...extensive experience in Regulatory Affairs with a successful track record in major...
- ...Name Associate Director, Regulatory Affairs – CMC Ref # 15322 Posting Date Tuesday... ...Schedule Full time Remote Work In office Job RI... ...to enable approval on the first review cycle. Effectively... ...Technical knowledge in small molecules with experience in translating...Remote workPermanent employmentFull timeTemporary workWork at office
- ...Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development... ...Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone...Remote job
- 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 job
$207.5k - $255.2k
...development and implementation of CMC regulatory strategy for small molecule investigational drugs in global... .... The Team You’ll Join As Director CMC Regulatory Affairs, you will be an essential member... ...Location & Compensation: This role is remote-friendly, with most work...Remote workWork at officeLocal areaWork from homeWorldwide$150k - $195k
....Position Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight... ...partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure... ...No role is expected to be 100% remote.Travere is an EEO/AA/Veteran/...Remote workFull timeContract workTemporary work$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible... ...products in the small molecule portfolio. This role... ...Pharmacy, Regulatory Affairs, Pharmaceutical... ...as: 1. Hybrid: work remotely up to two days per week...Remote workFull timeSummer workFlexible hours2 days per week- Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs across US, EU and ROW. You’ll coordinate internal and external contributors and drive region‑specific CMC documents (Module 2/3,...Remote job
- Recursion is seeking a Director CMC Regulatory Affairs to lead global regulatory strategy for small molecule drugs in early to late-stage trials. You will influence US, EU, and... ...GMP and trial requirements. The role is remote-friendly with some travel to Salt Lake City...Remote job
$285k - $320k
...This model allows science and small teams of experts to lead the... ...of work. What You'll Do Lead CMC regulatory strategy and execution across... ...ll Work This is a U.S.-based remote role that will require... ...preferred. Extensive Regulatory Affairs CMC experience within the biotechnology...Remote workWork at officeFlexible hours$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type:... ...of MASH. Rezdiffra is the first and only medication approved... ...and operational regulatory CMC leadership to support clinical... ...life cycle management of small molecule products.* Demonstrated experience...Minimum wageFull timeLocal areaFlexible hours- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory... ...-stage submissions; small-molecule experience is preferred.Ability... ...potential best-in-class and first-in-class clinical assets,...Work at officeFlexible hours
$177.4k - $238.96k
...oncology company committed to developing first-in-class and best-in-class... ...OverviewImmunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and... ...CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates...Flexible hours$177k - $278.08k
...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 workMinimum wageTemporary workLocal areaWorldwide$132k - $172k
...patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...registration milestones, including first marketing applications and global... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere provides...Remote workFull timeTemporary workWorldwide$188k - $215k
...model allowsscience and small teams of experts to... ...Manager / Associate Director, CMC Regulatory Sciences reports to the... ...) and Regulatory Affairs to design and implement... ...Collaborate with small molecule CMC technical teams... ...week. A US‑based fully remote role may be...Remote workFull timeWork at officeLocal areaFlexible hours$280k - $310k
...done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... ...with Health Authorities, and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs.Effectively...Local area$238k - $374k
...-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide... ...classified as "hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation and...Remote workMinimum wageTemporary workWork at officeLocal areaWorldwide$75 - $95 per hour
...thrive in a science-first culture with many... ...the Team: The Small Molecule, Process Chemist will... ...closely with the Director, Drug Substance Development... ...in a virtual CMC and pharmaceutical... ...of CGMPs, regulatory guidance, and compendial... ...This position is remote and may require limited...Remote workContract workTemporary workPart timeFor contractorsWork at officeFlexible hours- Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company Overview Founded over... ...autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible... ...a dynamic workplace that balances remote work flexibility with the benefits of...Remote workContract work
$200k - $250k
...Senior Director, Regulatory Strategy Consulting 4 days... ...ago – Be among the first 25 applicants... ...President, Regulatory Affairs, the Senior... .... Work Location: Remote position. Travel... ...and/or regulatory CMC. Experience across... ...proteins, mABs, ADCs), small molecules, cell and gene...Remote workFull time$220k - $250k
...SUMMARY: Responsible for providing regulatory strategic support for global regulatory... ...Marketing applications). This role will provide CMC regulatory support and guidance for... ...Industry with direct experience with small molecule/biologic technical functions. Minimum...Flexible hours$220k - $270k
...the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is... ...and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and...H1bCurrently hiring$230k - $270k
...lead program, Soquelitnib, is a first-in-class, oral therapy that... ...Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of... ...strategies for clinical-stage small molecule programs. This individual will...Full time
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