- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outsourced or contracted activities utilizing both performance and quality measurements.The Associate Director , SCBM Financial Reporting & Strategy position ... management and liaises with internal/external stakeholders on cross-functional initiatives.The Associate Director , SCBM Financial Reporting & Strategy's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... CMC regulatory compliance activities for portfolio biologics to meet US , International Conference on Harmonization (ICH), and other applicable regulations. This… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Associate Director , Regulatory Affairs** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the ... consumer and Catalent employee. The primary duty of the ** Associate Director , Regulatory Affairs** is...the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director Regulatory Process Development - 2406185269W **Description** At Johnson & Johnson, we believe health is everything. Our strength in ... at https://www.jnj.com/. **Johnson & Johnson Innovative Medicine, is recruiting for an Associate Director , Regulatory Process Development (RPD).** The… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs ( US RA AdPromo) as a...to the promotion of prescription drugs in the Uniteed States + The individual will require strong verbal and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience with ex- US … more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... of prescription drugs, biologics, and devices. **ESSENTIAL FUNCTIONS** + Provide regulatory leadership and guidance to Commercial teams during the development,… more
- Sanofi Group (Bridgewater, NJ)
- …time to prepare care plans for a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of the Global ... Biology, Life Science, or related field) preferred **Experience/Professional requirements:** + US regulatory expertise in post-marketing activities required + At… more
- Sanofi Group (Bridgewater, NJ)
- **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... Life Science, or related field) preferred **Experience/Professional** **requirements:** + US regulatory expertise in pre-marketing/development activities required… more
- AbbVie (Branchburg, NJ)
- …with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , Director , or ... Director ), in the development and execution of the regulatory strategy. Assigned matters may have a moderate impact...Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Global Labeling Product Leader - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Biomarker Strategy, Interventional Oncology (INTO) - 2406184251W **Description** At Johnson & Johnson, we believe health is everything. Our ... at https://www.jnj.com/. Interventional Oncology (INTO) is recruiting for an Associate Director , Biomarker Strategy located in Spring...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... of study data of a clinical development program. The Associate Director leads in a matrix environment...Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate… more
- Sanofi Group (Bridgewater, NJ)
- About the job - US Medical Associate Director , Respiratory **Our Team:** This position will report into the US Medical Immunology team which is a segment ... improve the lives of patients. **Job Description:** This position reports to the US Senior Medical Director , Respiratory. Main job responsibilities: + Develop… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Pharmacology and Pharmacometrics - 2306103445W **Description** Janssen Research & Development, LLC is recruiting for an Associate ... patient population, and treatment paradigm. + Working knowledge of US , European, and Asian regulatory requirements and...Working knowledge of US , European, and Asian regulatory requirements and guidelines. + Good oral and written… more
