- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … 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
- Merck & Co. (Rahway, NJ)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Kyowa Kirin North America (Princeton, NJ)
- …NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs , Advertising and Promotion ... ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA Form 2253… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and ... in alignment with overall business objectives. Relationships Reports to the Sr. Director , Wegovy Consumer Marketing . C ollaborates with sales, marketing, training,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Urban Resource Institute (New York, NY)
- …with Associate Vice President of Justice Initiatives and Senior Director of Clinical Services, monitor equity metrics for staff and client satisfaction ... in the sector across the US and beyond. POSITION OVERVIEW The Clinical Director provides strategic leadership to Urban Resource Institute's clinical staff and across… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …a difference with. The opportunity We are seeking an experienced and strategic IT Associate Director to support the Access & Value team within our Commercial ... (eg, HIPAA, GDPR). Cross-Functional Collaboration Work closely with Commercial, Medical Affairs , Regulatory , and Legal teams to ensure technology solutions… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for… 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
- Merck (Rahway, NJ)
- … issues to GRACS CMC management, as needed + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... **Job Description** GRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … more
- Merck (Rahway, NJ)
- **Job Description** ** Associate Director , Business System Labeling Management** **Required experience and skills:** + Min. 5-10 years of experience with ... Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or...as possible. **Job Description:** Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director or ... projects in their assigned therapeutic area portfolio. **Responsibilities** The Associate Director will be responsible to: + Develop regulatory strategy for… more
- J&J Family of Companies (Raritan, NJ)
- …more at https://www.jnj.com/innovative-medicine We are searching for the best talent for the Associate Director , Global Medical Affairs Strategy & Execution ... to be in Raritan, NJ. The Associate Director , Global Medical Affairs ...Janssen R&D clinical scientists, global and regional marketing directors, regulatory leaders, outcomes research and statisticians. External interactions with… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , WW Medical Cell Therapy Autoimmune, LCM/Pan-Indication, will ... When appropriate, they will also support the execution of BMS sponsored Medical Affairs trials, and assist in the evaluation and support of collaborative and… more
- Publicis Groupe (New York, NY)
- …is present in more than sixty countries with over 23,000 employees worldwide. **Overview** The Associate Director of Business Affairs is an integral part of ... In particular, identify risk relating to intellectual property, the regulatory environment, SAG-AFTRA Union regulations etc., Ensure agency standard methodologies… more
