- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning 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, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-… 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)
- …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 ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the… 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
- 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)
- **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro ... of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department...We set the bar high, and we deliver. Join us and together we will build on our trusted… 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
- Sanofi Group (Bridgewater, NJ)
- ** Associate Director , Vaccine Marketing, US ** + Location: Bridgewater, NJ **Our Team:** The US Vaccine Marketing and Commercial Strategy team establishes ... of patients around the world. **About the Job** The Associate Director , Marketing will report to a...of Consumer DTC/patient marketing experience + Experience in the US Market + Previous launch experience preferred + Pediatric,… 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
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Cell Therapy Operations - 2406188434W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare ... innovation empowers us to build a world where complex diseases are...https://www.jnj.com/. Janssen Global Services, LLC is recruiting for an Associate Director , Global Cell Therapy Commercial Operations… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures ... to manage one or more clinical scientists. As an Associate Director , a typical day may include...Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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
