- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- The MENA Catalysts, Inc. (San Francisco, CA)
- …is looking for a senior director of fintech legislative and regulatory affairs , for global clients, expanding in the Middle Eastern economies. The ... in a clear, professional manner.AdvantageousExtensive startup experiencePreferred field(s) of study: International business legislative and regulatory affairs … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical Affairs ,… more
- Merck & Co. (Rahway, NJ)
- …is part of our company's Social Business Innovation (SBI) department within Corporate Affairs . The ESG team works cross-functionally with senior leaders and ... and healthy future for people and communities everywhere.The role of Associate Director , ESG Strategic Reporting is a unique opportunity to join our company… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Director ( Senior Principal Scientist) has primary responsibility… more
