Director, CMC Regulatory Affairs - Small Molecules
$176.4k - $228.25kRecursion
Recursion is seeking a Manager/Director of CMC Regulatory Affairs in New York. In this role, you will lead the development of regulatory strategies for clinical trials, ensure high-quality submissions, and manage complex projects. Ideal candidates will have deep technical knowledge and experience in regulatory affairs, with a focus on small molecules. Recursion offers competitive compensation between $176,400 and $228,250, as well as an annual bonus and equity. Remote work is considered, but on-site visits are expected regularly. #J-18808-Ljbffr Recursion
- The Regulatory Affairs CMC will lead global CMC regulatory strategies for development and commercial... ...global regulatory requirements. The Director will serve as the CMC regulatory lead... ...Knowledge Deep understanding of small molecules development (Biologics, gene therapy,...SuggestedContract work
- EPM Scientific is seeking a Director of Drug Substance CMC to lead the development of innovative small molecule therapeutics in New York. In this critical leadership role... ...substance strategy and ensure compliance with regulatory expectations while collaborating with cross...Suggested
$176.4k - $228.25k
...’ll Make Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical... ...and guidance. The Team You’ll Join As Manager/Director CMC Regulatory Affairs you will be an essential member of the Recursion...SuggestedLocal areaRemote workWork from homeWorldwide$157.2k - $256.6k
...As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology... ..., mentor CMC Regulatory Affairs (RA) staff, supporting cross... ...Proven track record supporting small molecule drugs and/or biological...SuggestedWork at officeLocal areaRemote workWorldwideRelocation package3 days per week- ...Pharma (NAP) is seeking a Senior Manager CMC Regulatory Affairs who will support the development and... ...and will report to the Senior Director CMC Regulatory Affairs. Key Responsibilities... ...control strategies; experience with small molecules preferred. Experience working with...SuggestedLocal areaRemote work
$115k - $145k
...is seeking a Manager/Senior Manager, Regulatory CMC. This role provides regulatory Chemistry... ...the regulatory aspects of the CMC for small molecules. The Manager, Regulatory CMC with... ...The role will report to the Executive Director, Regulatory CMC. This role is based at...Work at officeLocal areaRemote work3 days per week$175k - $215k
...seeking an Associate Director/Director, Technical Operations... ...- Drug Substance (Small Molecules) to provide technical... ...leader within CMC, partnering closely with... ...functional teams (QA, QC, Regulatory, R&D, and Supply Chain... ...with QA, QC, Regulatory Affairs, R&D, and Supply Chain...Local areaRemote work3 days per week$155k - $205k
...progress toward our first regulatory approvals, with additional... ...re seeking an experienced Director Regulatory Affairs, Clinical to serve as Loyal... ...functions (including R&D, CMC, and commercial)... ...multiple drug types ideal (small molecules, biologics, injectables, etc...Home officeWeekend work$130k - $200k
...Join to apply for the Associate Director Regulatory Affairs role at Tonix Pharmaceuticals Join to apply... ...related mainly to novel biologics (large molecule/infectious disease, autoimmune disease... ..., Gene Therapy Associate Director, CMC Regulatory Affairs United States $170,...Full timeTemporary workWork at officeLocal areaRemote workFlexible hours- Fosun Pharma USA Inc. is seeking a Regulatory Affairs CMC leader to steer global CMC regulatory strategies for development and commercial products... ...compliance with global regulatory requirements. The Director will lead cross-functional teams, mentor staff, interact with...
$246.33k - $304.29k
...Job Summary Senior Director, Regulatory Affairs to lead global regulatory strategy for vadadustat and support... ...sub-teams (e.g., Product, Clinical, CMC). Proactively identify and mitigate... ...management experience. Experience in small/start‑up biotech environment; hands‑on...$200k - $250k
Senior Director, Regulatory Strategy Consulting 4 days ago - Be among the first... ...Vice President, Regulatory Affairs, the Senior Director... ...development, and/or regulatory CMC. Experience across... ...biologics (proteins, mABs, ADCs), small molecules, cell and gene therapy, oligonucleotides...Full timeRemote work$140k - $160k
Iovance Biotherapeutics is seeking a Manager, Regulatory Affairs CMC to spearhead the planning, compilation, and submission of Investigational Drug Applications. Responsibilities include working with diverse internal teams and negotiating with stakeholders to align submissions...- Iovance Biotherapeutics is seeking a Director, Regulatory CMC to oversee drug development programs and regulatory strategy. You will lead cross... ...authorities. With a minimum of 10 years of experience in regulatory affairs, especially in oncology, you will be responsible for...
- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology... ...in women's health therapeutics and a background in small to mid-size biotech companies are also strongly preferred....
$175k - $215k
Axsome Therapeutics, Inc. is hiring an Associate Director/Director, Technical Operations in New York City. This role focuses on overseeing drug substance manufacturing, ensuring regulatory compliance, and providing technical leadership. Ideal candidates have advanced degrees...$228k - $233k
...careers, even as we continue to grow. Job Overview: The Director, Global Regulatory Affairs leads Protara’s ex-US regulatory strategy and operational... ...submissions and regulatory meetings. Strong understanding of CMC, nonclinical, and clinical requirements for advanced...Local areaRemote workFlexible hours- ...Avalon Therapeutics seeks a strategic and execution-focused Director of Regulatory Affairs to provide global regulatory leadership for abdakibart (... ...pharmaceutical industry. Minimum of 5 years of experience within a small or emerging biotechnology company preferred. Demonstrated...
$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory... ..., Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial, and Executive...Temporary workLocal areaRemote workWeekend work- ...lives – cancer free. The role: The Senior Associate, Regulatory Affairs will be a key individual contributor on a small, high-impact regulatory team and will report... ...work cross-functionally with Clinical Development, CMC, Quality, Research, and external partners such as...Flexible hours
$220k - $300k
...Pathos with us. About the role Pathos is seeking a Head of Regulatory Affairs to lead the regulatory function across the organization. This... ...representative to the FDA. This is a strategic and hands-on role. In a small and growing biotech, you will define regulatory strategy...Work at office3 days per week$125k - $165k
Garner Health, based in New York, is seeking a Strategic Accounts Executive to support and grow the small group market by guiding employer clients on benefits and plan performance. This role involves retaining and upselling clients while collaborating with the Client Success...Remote job- JCW Group is seeking a candidate to lead a specialty P&C carrier's small commercial franchise in New York. This role offers complete P&L ownership, including strategy shaping across underwriting, pricing, and distribution. The ideal candidate will have a solid background...
- ...Executive Director Of Translational Strategy And Innovation The Executive Director... ..., including cell and gene therapies, small and large molecules, and antibody-based therapeutics.... ...Analysis: Conduct market, scientific, regulatory and clinical opportunity assessments...Local area
$176k - $236k
General Description The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting... ...management and regulatory submissions, including both small molecules and biologics, with significant global exposure. •...Work at officeWorldwide- City National Bank in New York is looking for a dedicated professional responsible for acquiring small business and personal clients. The ideal candidate will act as a strategic advisor, providing sound financial advice and fostering client relationships. This role requires...
- Veeva, a mission-driven pioneer in life sciences industry cloud, is hiring a General Manager, CMC to own all aspects of building this new business. Reporting to the VP of Regulatory, you will lead a high‑performing team to deliver applications and capabilities, navigate...
$94k - $147.95k
...difference. Chobani’s Manager of Sales Planning for Emerging Small Format will craft, implement, & track the Emerging Channel’s go... ...impact the marketplace. This position will report directly to the Director of Sales Planning, and work in close partnership with Sales...Full timeTemporary workWork at officeLocal areaFlexible hours- ...serve a wide range of customers from personal users, freelancers, small businesses and increasingly even to large enterprises and banks... ...for Wise US Inc. Horizon scanning of new FinCrime regulatory developments and maintaining oversight of implementation of such...Full timeFreelanceWork at office
- ...private wealth management, personal and small business financial solutions, as well as... ...operations across North America. As the Director, US Sanctions Compliance, you'll report... ...sanctions screening operations, ensuring regulatory compliance, and promoting a strong risk...Remote work3 days per week
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