- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for ... reviewing the CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a healthcare industry required- 4 or More… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC data or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Merck & Co. (Rahway, NJ)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Organon & Co. (Jersey City, NJ)
- …**The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The role of Associate Director , Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters ... Director of Medical Affairs Outcomes Research. Focusing...priorities. Developing and implementing patient-centred endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is… more
- Sumitomo Pharma (Trenton, NJ)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... in the pharmaceutical industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be managing a significant number of generic… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and… more
- United Therapeutics (Trenton, NJ)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: Regulatory expert in the area of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject ... and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory … more
- Veterans Affairs, Veterans Health Administration (East Orange, NJ)
- …Healthcare System in the Senior Executive Service (SES). Responsibilities Major Duties: The Associate Director (AD), along with the Executive Leadership Team has ... a virtual position. Position Description/PD#: Health Systems Administrator - Associate Director /PD99902S Financial Disclosure Report: Required Requirements… more
- Bristol Myers Squibb (Princeton, NJ)
- …brings an expertise in regulatory affairs and related policy. The Associate Director , Regulatory Policy is responsible for driving regulatory ... careers.bms.com/working-with-us . **Job Purpose:** This position is focused on regulatory policy to ensure appropriate and effective regulatory...team, the Associate Director Regulatory Policy… more
- J&J Family of Companies (Titusville, NJ)
- …America, Titusville, New Jersey, United States of America **Job Description:** **Senior Manager/ Associate Director , Regulatory Medical Writing X-TA** At ... We are searching for the best talent for a **Senior Manager** **/ Associate Director ** , ** Regulatory Medical Writing** within our… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Labeling Product Leader. This position is a hybrid… more
- Philips (Mercerville, NJ)
- ** Associate Director , Field Medical Lead** The Associate Director , Field Medical Lead develops and implements strategic medical plans aligned with ... company policies. + Collaborates with cross-functional teams, including Marketing, Quality, Regulatory , and Clinical Affairs , to drive product advancement,… more
