Remote Regulatory CMC Lead Small Molecule + Veeva RIM
Syneos Health Inc
- Remote job
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 Syneos Health Inc
- 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
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- Beeline Medicines seeks a Director, CMC Product Development - Small Molecule to lead end‑to‑end drug product development from early formulation through process development, clinical supplies and regulatory submission. The role integrates with internal teams and external...Regulatory
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$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- 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
- ...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 timeContract workInterim role
- ...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
$187.8k - $208.6k
...Nurix Therapeutics seeks a Senior Manager or Associate Director to lead CMC regulatory strategy for small molecule programs from clinical development through commercialization. The role combines hands-on authoring of Module 3 submissions with strategic cross-functional...Regulatory$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$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$187.8k - $208.6k
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) Brisbane, California Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development...RegulatoryLocal area- Dechra Pharmaceuticals PLC seeks a Regulatory Affairs Senior Principal Scientist to lead regulatory strategies for traditional small‑molecule drugs and large‑molecule biotherapeutics in the US. You will guide submissions, liaise with FDA CVM/USDA CVB, and mentor the US...Regulatory
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...The Associate Director, Regulatory Operations – Veeva Vault RIM is a key member of the Regulatory... ...Technology, Clinical, CMC, Pharmacovigilance,... ...data and process governance, leads system enhancements and release... .... This role is fully remote. Primary...Remote workRegulatoryFull timeFor contractorsWork at officeLocal area- Role Lead and mentor the Oligonucleotide & Small Molecule CMC Analytical Development team, providing scientific leadership in analytical method development,... ...across discovery, process chemistry, quality, and regulatory teams. Manage external analytical work and author...Regulatory
- ...validation, and transfer of analytical and biological potency assays for large molecules. You will oversee stability studies, coordinate CRO/CMO activities, and contribute to CMC sections for regulatory submissions. The role requires strong leadership, regulatory acumen, and...Regulatory
$212k - $333.19k
...build, we are seeking a Head of Small Molecule In Vitro Pharmacology. This... ...across discovery, build and lead a distributed team, and collaborate... ..., advisory boards, and regulatory interactions and contribute to... ...” by Takeda’s Hybrid and Remote Work policyTakeda Compensation...Remote workRegulatoryMinimum wageLocal area- ...Therapeutics is seeking a Senior Director of Analytical Sciences to lead analytical strategy and lifecycle management across the drug... ...drug product portfolio. You will drive alignment with quality, regulatory, manufacturing, and supply chains while guiding external...Remote jobRegulatory
- ...Senior CRM Configuration Lead (Veeva/Salesforce - Life Sciences) Location: Remote (EST time) Duration: Long term Note: We need resource in... ...Loft). This role supports commercial, medical, and regulatory operations, ensuring systems are aligned with...Remote workRegulatoryImmediate start
- ...Marketing Operations & MLR Specialist to own Veeva Vault PromoMats workflows and manage MLR reviews across Medical, Legal, Regulatory, and Marketing stakeholders. The role... ...communication in a fast-paced, regulated environment. Remote work options may be available with...Remote workRegulatory
$200k - $290k
...milestones. We are a small, focused team... ...Director of CMC Quality... ...Operations Location: Remote (U.S.) What You... ...clinical assets and regulatory submissions.... ...controls; lead OOS/OOT and deviation... ...and small molecule development. Ability... ...such as Veeva Vault, TrackWise...Remote workRegulatoryContract workFlexible hours$103.13k - $165k
Company DescriptionCRB is a leading provider of sustainable engineering... ...or V with deep expertise in small molecule manufacturing to join our... ...scale-up, optimization, and regulatory compliance across a variety... ...near any CRB location, remote option will be consideredKey...Remote workRegulatory$159k - $207k
...of delivering meaningful therapeutics to patients. Lead and mentor the Oligonucleotide & Small Molecule CMC Analytical Development team while providing hands‑... ...capabilities, external analytical work, and regulatory documentation, collaborating across teams to resolve...RegulatoryLocal area- Veeva Systems is a mission-driven organization and pioneer... ...industry experience in Regulatory Operations or... ...Information Management (RIM) products in Europe. If... ...the Veeva RIM community, lead educational campaigns,... ...teams, both in-person and remote. Strong analytical...Remote workRegulatoryWork at officeWork from home
$150k - $215k
...via device-enabled therapeutics. Indomo’s lead program couples a proven corticosteroid... ...are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing... ...of our lead asset through the NDA regulatory pathway, while effectively coordinating...Remote workRegulatoryFull timeLocal area$185k - $256k
...discovery. We offer a dynamic, remote-friendly environment... ...leader and SME in CMC Chemistry, Manufacturing... ...is a core part of our Molecule to Market story. We need... ..., including CMC Leads, MSAT, Pharmaceutical Sciences... ...and Quality, and Regulatory CMC Build positioning...Remote workRegulatoryFull timeWork experience placementImmediate startFlexible hours- ...Job Description Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC strategy for biologic... ...office or Headquarters in Paris (France) Flexible for this to be Boston-office based, remote East-coast (USA) or hybrid....Remote workRegulatoryWork at officeFlexible hours
- ...diseases. See Yourself at Telix As the CMC Program Lead covering Illuccix and Gozellix, you... ...Validation, Quality, Clinical Ops, and Regulatory Establish and maintain CMC project... ...precision medicine. We have hybrid and remote employees located all around the world....Remote workRegulatoryFull timeContract work
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