- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …range for director level candidates is between $200,000-$235,000 and associate director level candidates is between $160,000-$180,000. The final salary ... important to us as an organization.The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio...working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... our Monmouth Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job Title… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Novo Nordisk Inc. (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... development and scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel strategies towards… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …our program partner Janssen. This effort will extend to joint technical and CMC committees that report to the Joint Manufacturing Committee in the commercial ... efforts worldwide.Key Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior leadership to achieve global alignment… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs ... process of manufacturing AAV based therapies. Working closely with Process Development and CMC teams you will be the bridge between the laboratory and GMP… more
- Avidity Biosciences, Inc. (San Diego, CA)
- Job Title: Associate Director , Regulatory AffairsLocation:San Diego, CA / Hybrid / RemotePosition type:Full timeFLSA:ExemptDepartment:Regulatory and QualityStrive ... and engage with us on LinkedIn and Twitter.The OpportunityReporting to the Director , CMC Regulatory Affairs, the successful candidate will work independently… more
- AstraZeneca GmbH (Boston, MA)
- This is what you will do:Position SummaryThe Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA- CMC ) will be ... responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio.You will be responsible for:Job Duties and… more
- Kyverna Therapeutics, Inc. (Emeryville, CA)
- …transform how autoimmune diseases are treated.Kyverna is seeking an experienced and passionate Associate Director , CMC Regulatory Affairs with a strong ... T therapy. This position is responsible for providing Regulatory CMC strategies and leading the preparation of submissions and...are looking for candidates with 3-5+ years of direct CMC Regulatory Affairs experience who are eager to contribute… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsJob DescriptionAt Gilead, we're creating a healthier world ... their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Associate Director , Analytical Regulatory Science, collaborates with product… more
- PSG Global Solutions (Cambridge, MA)
- DescriptionWe're looking for an Associate Director Regulatory Affairs CMC , working in the Pharmaceuticals and Medical Products industry in Cambridge, ... United States.Responsibilities:Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach… more
- Neogene Therapeutics (Santa Monica, CA)
- …and based in Santa Monica, CA and reports to the Executive Director , CMC Regulatory Affairs.ResponsibilitiesInterpret global regulations and guidance to identify ... innovations to achieve the next wave of breakthroughs.Position SummaryThe AD CMC Regulatory Affairs supports the development and successful performance of the… more
- Novo Nordisk Inc. (Boulder, CO)
- …with all applicable environmental, health and safety regulations. Relationships Reports to Associate Director , EHS at US headquarters in MA. Internal ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …advanced degree preferred.At least 8+ years of regulatory affairs experience for the associate director or 10+ years of Regulatory affairs experience for the ... working closely with cross-functional colleagues including regulatory operations, quality, CMC , nonclinical and clinical team members. S/he will be... director in the pharmaceutical or biotechnology industry Experience in… more
- Scismic (Boston, MA)
- …that is discovering and developing novel medicines for cancer.We are seeking an Associate Director / Director of Regulatory Affairs to join the company. ... for product development including the areas of clinical research, CMC , regulatory operations, nonclinical study requirements and regulatory complianceWork… more
