- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management ... (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical ... adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor… 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 ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we ... difference with. **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ) to write, review and compile… more
- System One (Florham Park, NJ)
- Senior Manager , Regulatory Affairs (BRANDED PRODUCTS) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview The ... Contractor - Senior Manager , Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management ... (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC ... entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory … more
- Haleon (Warren, NJ)
- …Care to join us. It isn't a question. **About the role** The **Senior Manager , US Regulatory Affairs -Wellness** is responsible for end-to-end regulatory ... Nutrition, Food Science Biology, Chemistry) + 7+ years of experience with Regulatory Affairs + 5+ years working specifically in US dietary supplements, or… more
- Englewood Lab, Inc (Totowa, NJ)
- Reports to: Manager of Regulatory Affairs Responsibilities: + Assist the Manager of Regulatory Affairs during cGMP, Environmental, and ... direct supervision of the Head of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The candidate will be leading the regulatory strategies for biologic products and combination products for the product portfolio assigned. **In this role, a typical ... + Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements… more
- Deloitte (New York, NY)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... a digitally enabled, equitable future of health As a Manager in our AI & Data team, you will...+ Veeva RIM and/or QMS implementation + Understanding of regulatory data and regulatory filing requirements +… more
- Deloitte (New York, NY)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... digitally enabled, equitable future of health As a Senior Manager in our AI & Data team are expected...+ Veeva RIM and/or QMS implementation + Understanding of regulatory data and regulatory filing requirements +… more
- Bayer (Whippany, NJ)
- …**Reference Code:** 829446 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Regulatory Affairs , Compliance, Operations Manager , Law, ... to make a real difference, there's only one choice.** **Assistant Director Regulatory Affairs North America Operations** The Assistant Director Regulatory… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +...one. Please ensure you have discussed with your current manager the intent of applying to a new role.… more
- Englewood Lab, Inc (Totowa, NJ)
- Responsibilities + Assist the Manager during cGMP, Environmental, and Regulatory audits. + Assist the Manager to create and collate product master files ... the direct supervision of the Head of Quality. + Assist the Manager during periodic regulatory reviews, regulatory updates, and annual GMP training. +… more
- Bausch Health (Bridgewater, NJ)
- …the processes of booth activities + Works cross-functionally with other Medical Affairs , Regulatory , Pharmacovigilance matrix team members, as necessary + ... values drive our collective progress and impact. The Medical Information Manager will effectively communicate accurate, scientific, and balanced medical information… more
