Remote Regulatory CMC Lead Small Molecule + Veeva RIM
Syneos Health Inc
Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant for small molecule programs and Veeva RIM. The role focuses on leading regulatory activities across multiple regions with a strong emphasis on INDs, product registrations, and post-approval maintenance. Remote, ON, Canada-based opportunities are available for qualified candidates. The incumbent will oversee project teams, contribute to strategy, and provide regulatory guidance to colleagues and clients, while coordinating #J-18808-Ljbffr
- ...Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have (EMEA /LATAM/Canada) Location: Remote, ON, Canada Description Mgr/Sr Regulatory CMC Consultant - Small Molecule... .../LATAM/Canada) Syneos Health® is a leading fully-integrated life sciences services...Remote workRegulatoryContract work
- ...Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant focused on small molecule programs and Veeva RIM. Located remotely in the US, you will lead CMC lifecycle submissions, review regulatory CMC content for FDA/EMA/Health Canada, and partner with cross-functional...Remote workRegulatory
- ...PTC Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs – CMC to lead global CMC strategy for small molecule development and registration. You will coordinate cross-functionally with Technical Operations, Quality, and Regulatory Affairs to ensure timely...Regulatory
- ...Nurix Therapeutics is seeking an Associate Director-level Regulatory Affairs CMC to shape the regulatory path for our small molecule portfolio from development through lifecycle. You will author Module 3 content, guide global submissions, and mentor junior staff while...Regulatory
- ...Lilly, headquartered in Indianapolis, Indiana, is seeking a regulatory CMC leader to drive strategic, tactical, and operational CMC activities... ...across modalities and technologies to accelerate the small molecule portfolio. You will guide development teams, craft regulatory...Remote workRegulatory
- ...on rare diseases, seeks a Director of Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing... ...at Travere CDMOs. You will collaborate across Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestones are...Remote workRegulatory
- ...Travere Therapeutics in San Diego (Remote) seeks an Associate Director, Technical Operations (Small Molecule CMC) to provide technical... ...You will partner with Quality, Regulatory Affairs, Clinical, and Supply... ...commercial readiness. You will lead process development,...Remote workRegulatory
- ...an Associate Director, CMC, Drug Substance to... ...and manufacturing of small molecule APIs for clinical trials... ...development via CDMOs, lead tech transfer, and align... ..., while authoring regulatory CMC sections for IND/NDA... ...Travel up to 15% and remote options may apply; strong...Remote workRegulatory
- ...CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing... ...with Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone alignment...Remote jobRegulatory
- ...CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing... ...molecule drug products. You will partner with Quality, Regulatory Affairs, Clinical and Supply Chain to ensure alignment, risk...Remote workRegulatory
- Role: Associate Director, CMC Regulatory Affairs, providing strategic and... ...activities related to small molecule drug products, primarily oral... ...CMC regulatory strategies; lead regulatory submissions (INDs... ...regulatory agencies. Work Setup remote with some travel (~10%), onsite...Remote workRegulatory
- ...Therapeutics is seeking a Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing... ...API programs with global CDMO oversight and regulatory documentation leadership. Remote with 10-20% travel; collaboration with cross-functional...Remote jobRegulatory
$150k - $195k
...pursue our vision of becoming a leading biopharmaceutical company... ..., Technical Operations (Small Molecule CMC) will provide technical oversight... ...closely with Quality, Regulatory Affairs, Clinical, and Supply... ...role is expected to be 100% remote.Travere is an EEO/AA/Veteran...Remote workRegulatoryFull timeContract workTemporary work- 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
- Scorpion Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic and operational... ...activities spanning development to commercialization of small molecule oral solid dosage forms. The role leads CMC submissions (INDs, NDAs), serves as primary...Remote jobRegulatory
- ...Scorpion Therapeutics is seeking a Senior CMC Director to lead the development and execution of CMC strategies for small molecule programs from Phase I through commercial.... ..., and cGMP manufacturing, while reviewing regulatory filings and ensuring compliance. You will...Remote workRegulatory
- ...identifying functional leads in a single... ...includes programs in small cell lung cancer,... ...for someone to own CMC for it end to end,... ...risks early. The molecule is a multispecific... ...or QC, and enough regulatory fluency to defend... ...1 program today. Remote is fine and we have...Remote workRegulatoryPermanent employmentFull timeInterim role
- ...Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and... ...and commercialization. The role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones...Regulatory
- Latigo Biotherapeutics, Inc. seeks an Associate Director of CMC, Drug Substance to lead development activities from preclinical through clinical... ...with CDMOs, ensure cGMP compliance, contribute to regulatory submissions, manage external partnerships, and work with...Regulatory
- ...Therapeutics seeks a senior scientist to lead and mentor the CMC Analytical Development team, overseeing... ...analytical strategy across oligonucleotide and small-molecule programs, validate methods, and coordinate CROs/CDMOs and regulatory submissions, ensuring rigorous GxP...Regulatory
- ...We are seeking an experienced Regulatory Affairs CMC leader to provide strategic, operational, and... ...and lifecycle management activities. Lead CMC regulatory planning and support... ...audiences. Preferred Experience supporting small molecule and/or advanced therapeutic products....Regulatory
$274.8k - $354.8k
...importantly, share our passionate interest in fighting cancer. The CMC Lead is a strategic and cross-functional leader responsible for... ...for assigned drug programs from clinical development through regulatory submission, approval, and commercialization. The CMC Lead serves...RegulatoryHourly payLocal areaWorldwide- ...Veeva Systems is seeking an experienced MedTech Regulatory Information Management (RIM) consultant to lead implementation workstreams globally. You will guide transformation of Regulatory Affairs and Operations using industry-leading technology, collaborating with Professional...Remote workRegulatory
$187.8k - $208.6k
...Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development through marketed lifecycle. You'll combine hands-on authoring of Module 3 (Quality) content with real...RegulatoryLocal area- ...seeking an Associate Director of Technical Operations (Small Molecule CMC) to oversee API development and manufacturing... ...performance, while ensuring GMP quality systems, regulatory alignment, and timely IND/NDAs. Remote with travel and a focus on US/EU GMP standards will...Remote workRegulatory
$150k - $210k
...expertise in muscle biology and small molecule drug development, we are... ...position will contribute regulatory CMC experience to Edgewise cardiovascular... .... ~ Experience with Veeva RIM or similar document... ...with experience working in a remote environment. ~ Able to...Remote workRegulatoryFull timeFor contractors- ...Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs CMC to provide strategic and operational leadership for regulatory chemistry, manufacturing, and controls activities supporting clinical trials, market registrations, and post-approval submissions for...Regulatory
$242k - $313.5k
...Senior Director, Regulatory Affairs CMC – Small Molecule About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune...RegulatoryLocal area2 days per week$212k - $333.19k
...Head of Characterization Small Molecules in our Cambridge... ...ACCOUNTABILITIES:Define, lead, and deliver the extended... ...strategy across the CMC portfolio to support... ...experience supporting regulatory submissions and approval... ...Takeda’s Hybrid and Remote Work policy. #LI-JT1Takeda...Remote workRegulatoryMinimum wageWork at officeLocal area- ...Beeline Medicines seeks a Director, CMC Product Development – Small Molecule to lead end‑to‑end drug product development, from formulation and process development through clinical supplies and regulatory submission, working cross‑functionally with internal teams and external...Regulatory
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