- Vir Biotechnology, Inc. (San Francisco, CA)
- …Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all assigned ... products have a successful regulatory CMC strategy for clinical development and...health authorities and will have frequent interaction with internal senior management, corporate partners, international regulators and external experts.… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director / Senior ... their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as...responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Adverum Biotechnologies (Redwood City, CA)
- The Director /Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key ... Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance. The Director /Sr will be responsible...be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process and analytical development, technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics and ... reduction efforts worldwide.Key Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior leadership to achieve global… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Novo Nordisk Inc. (Boulder, CO)
- …small molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development. Essential Functions Lead the ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Collaborate with all Tris functions that contribute to the partnership, including R&D, Regulatory , CMC , Finance, Legal, and more. Understand their roles, their ... some combination across technical (eg, research, product development, clinical development, regulatory , CMC ) and business (eg, business development, alliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and cross functional partners.Key Responsibilities Represent MSAT at joint quality and CMC committeesPartner closely with senior Janssen leadership to achieve ... PPQ and comparability protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact… more
- Novo Nordisk Inc. (Boulder, CO)
- …and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions The successful ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...a difference? The Position Novo Nordisk is seeking a Senior Scientist to join our RNAi Chemical Development group… more
- Nova Anchora (Boston, MA)
- …product from academic development into the clinic, we are seeking a highly skilled and experienced Senior Director of CMC to lead this critical phase of our ... journey. The Senior Director of CMC will...journey. The Senior Director of CMC will play a pivotal...up to support later clinical studies and commercial licensure. Regulatory and Quality Compliance: Implement and manage CMC… more
- San Francisco (San Francisco, CA)
- …THE ROLE Reporting to the Vice President, CMC Operations, the Head of/ Senior Director CMC Operations (Drug Substance) will manage activities related ... Drug substance. Managing complex and intertwined scientific/technical and operational logistical CMC related activities, the position will support the Company's drug… more
- Indapta Therapeutics Inc. (San Francisco, CA)
- …The Position: Indapta seeks an experienced, biotech CMC quality professional at a director or senior director level. We offer the autonomy, excitement, ... moving from early to later phase clinical trials. Responsibilities will include: Lead the CMC QA function and partner with clinical, regulatory and CMC … more
- Dennis Partners (Boston, MA)
- …for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and execute on global ... with FDA and other regulatory agencies in conjunction with senior Regulatory leaders.Author/edit documents to support regulatory submissions.Compile,… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …and those of direct reports. Work is performed under direction of a Senior Regulatory Affairs professional. Contribute to internal regulatory policies ... offer a dynamic workplace for employees to grow and develop their skills.The Director , Regulatory Affairs will be responsible for developing and implementing… more
- Rezolute (Redwood City, CA)
- The Senior Director , Global Supply Chain will...and EU.The individual will work amongst a team of CMC experts in a matrix organization, capitalizing on each ... technical communication to Global Health Authorities in support of CMC preparation, CMC query resolution, and plant...RespectRezolute (RZLT) currently anticipates the base salary for the Senior Director , Global Supply Chain role could… more
- Atlas Venture (Boston, MA)
- Senior Director , Drug Product Development (Small Molecules)Company Address: 1 Winthrop Square, Suite 400, Boston, MA, 02110 About Scorpion TherapeuticsScorpion ... member of Project Development Teams, collaborate and partner closely with CMC project management, drug substance SMEs, DMPK/toxicology, clinical operations, … more
