- Merck & Co. (Rahway, NJ)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.- CMC RA : Experience supporting/writing ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Aequor (Basking Ridge, NJ)
- …in meeting study objective, Provide supporting information to the teams, in particular RA , RACMC, Clinical ops, and GPMs. Design packaging requirements; based on a ... including obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the labels. Ability… more
- Syner-G BioPharma Group (Boston, MA)
- …strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, ... phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in...execution, review, and closure of validation life cycle documents ( RA , VP, IQ, OQ, PQ, TM, VR).Write, review, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans.- Communicate with portfolio leaders in Clinical Development, Discovery, QCP, CDx, RA , MA or other relevant functions to ensure effective integration of ... translational pathology strategy into broader Translational/Program strategies Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college… more
- Evident Scientific (Needham, MA)
- Sr. Mgr., Regulatory Affairs ( RA ) & Clinical Affairs (Evident MIS) Job ID #: 2215 Company: Evident Posting Date: Nov 25, 2025 Are you looking for a ... Collaboration** + Lead coordination between Clinical Affairs , US regulatory operations, and Global RA teams to ensure consistent regulatory and clinical… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager, Regulatory Affairs ( RA ) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in ... team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs ( RA ) core or subteam member in projects as well… more
- Boehringer Ingelheim (Ridgefield, CT)
- …For assigned development projects and US marketed products, the Director, US Product Group Regulatory Affairs will provide expert US regulatory leadership to ... Regulatory strategy for assigned projects and represent US RA on US cross-functional teams. The Director, US Product...on US cross-functional teams. The Director, US Product Group Regulatory Affairs will act as primary company… more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory...with FDA that is aligned with project teams and RA Subteam. + Provide regulatory leadership to… more
- Philips (Plymouth, MN)
- …or more senior regulatory affairs specialists. Under the supervision of the Regulatory Affairs ( RA ) Manager or a more senior Regulatory ... **Intern - Regulatory Affairs - Minneapolis, MN - Summer...files, and similarly scoped updates/submissions. + Support more senior RA Specialists in the preparation of regulatory … more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …in global markets. **Responsibilities:** + Coordinates the global activities of the entire PIVC Regulatory Affairs ( RA ) staff + Works with platform and ... Become a **maker of possible** with us. The Director, Regulatory Affairs will be a member of...management as required to establish and periodically measure PIVC RA department goals and objectives which are consistent with… more
