- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... Years Experience in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory submissions in… more
- Proclinical Group (Boston, MA)
- Senior Director , Regulatory Affairs - Perm - Boston, MAProclinical is seeking a dynamic and strategic leader for the role of Senior Director of ... manage complex regulatory portfolios.Strong leadership skills and strategic thinking.The Senior Director , Regulatory Affairs ' responsibilities will… more
- Arcellx (Redwood City, CA)
- …set of views and backgrounds. How You'll Make a Difference As our Senior Director , Clinical Regulatory Affairs , you'll lead and drive Arcellx's clinical ... sciences (biology, pharmaceutical sciences, or equivalent). 12-15+ years of clinical regulatory affairs experience, including early and late phase research,… 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 ... development, regulatory , and registration strategies. What you'll do:Manage the Regulatory Affairs (CMC) Strategy for Regulatory AffairsStrengthen… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- AstraZeneca (Boston, MA)
- …Affairs is a respected voice and considered an equal partner in the business. The Senior Regulatory Affairs Director (SRAD), Global Regulatory ... our regulatory functions through the recruitment of Regulatory Affairs Strategists (at Director and Senior Director level). You will work across… more
- Dennis Partners (Boston, MA)
- …therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and ... and other regulatory agencies in conjunction with senior Regulatory leaders.Author/edit documents to support ...or PhD) preferred.Ten or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologic… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- The opportunity Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all ... position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and author high quality regulatory… more
- Pliantrx (San Francisco, CA)
- …support program recommendations.This position will report to the Senior Director of Regulatory Affairs .ResponsibilitiesDrive key kick-off regulatory ... Director , Regulatory Affairs and Quality Project ManagementPliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and… more
- Biolink360 (San Francisco, CA)
- … - San FranciscoWe are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This ... or related fieldAdvanced degree strongly preferred10+ years of experience in Regulatory Affairs submissions in a Senior /Principal/Program leadership… more
- Merck & Co. (North Wales, PA)
- …, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is ... divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a hybrid ... Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other responsibilities will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda for and ... Plan (EGP), in collaboration with Senior Medical Director Serve as NNI Medical Affairs representative...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate Director , Policy Strategy and Capabilities is ... the Strategic Planning & External Engagement team, reporting to the Executive Director , Policy Development & Strategy.The Associate Director will develop and… more
- Tris Pharma (Monmouth Junction, NJ)
- …to hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior ... compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates… more
