- 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
- 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
- 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… 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
- 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
- Scotiabank (New York, NY)
- Associate Director , Legal Counsel, Legal and Corporate Affairs **Requisition ID:** 206757 **Salary Range:** 180,000.00 - 224,700.00 _Please note that the ... advising the front office and other internal stakeholders on legal and regulatory matters related to the business. + Independently draft and/or assist the… 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
- Grifols Shared Services North America, Inc (Newark, NJ)
- …2 years of experience. **Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in the United States (non-California), is ... insights to internal stakeholders 12. Partner with patient advocacy, regulatory , HEOR, and market access to support US and...**For California:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents ... regulatory strategies, processes, standards, practices, efficiencies and capabilities. + Represents Regulatory Affairs and may serve as Regional Lead or… more
