- Novo Nordisk (Princeton, NJ)
- …or medical device/pharmaceutical combination product experience and actual regulatory experience + Advanced knowledge of pertinent FDA regulations ... Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop… more
- Philips (Hamilton, NJ)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' ... with the current portfolio in connection with future innovations. + Building FDA regulatory submissions strategy for the products portfolio, providing related… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Description The Sr Manager Regulatory Affairs represents US regulatory affairs ... understanding of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and provides regulatory … more
- Amgen (Washington, DC)
- …line management + Develop regulatory risks and predictions of interactions with regulatory agencies + Ensure regulatory product compliance for product ... time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional ...and develop relationships with points of contact at the FDA on specific product assignment + Document… more
- Boehringer Ingelheim (Ridgefield, CT)
- …by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups. All qualified applicants will ... Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US product labeling. The...Sheet (CCDS) Updates, and other ad hoc issues (eg, FDA requests for labeling changes). Draft/revise product … more
- Takeda Pharmaceuticals (Exton, PA)
- …best of my knowledge. **Job Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve as an ... internal expert on FDA regulations, guidance, and enforcement trends governing the promotion...regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to help ensure … more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …writing respective to a product recall or market withdrawal. The Manager , Regulatory Compliance supports with establishing new, revising and maintaining ... Description: The Manager , Regulatory Compliance, assembles a team...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard… more
- ThermoFisher Scientific (Fremont, CA)
- …R&D, Marketing, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the ... product lifecycle. * Develop global regulatory strategies for medical device products to meet business...lifecycle. * Ensure compliance with Thermo Fisher Scientific, US FDA , EU MDR/IVDR, Korea MFDS, China NMPA and other… more
- Danaher Corporation (West Sacramento, CA)
- …compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). In ... tools that address the world's biggest health challenges. The Regulatory Affairs Manager for Beckman Coulter Diagnostics...impact on business activities and operations. + Serves as regulatory affairs liaison and interfaces with FDA … more
- AbbVie (South San Francisco, CA)
- …with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP). Qualifications ... execution of the regulatory strategy. + Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory ... understanding of regulations for device products, leads and participates in global regulatory product teams, interprets regulations, and provides regulatory … more
- AbbVie (North Chicago, IL)
- …compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). ... are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Responsibilities: + Responsible for a product (s) or products… more
- Actalent (Jackson, WI)
- Job Title: Regulatory Manager Job Description Manage and...+ FDA cGMPs + Audit Management + Regulatory Reporting + Product Registrations + Document ... of departmental functions including managing audits (internal and external), annual regulatory reporting, recall program, regulatory product registrations,… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …team meetings, and joint labeling meetings with partner companies + May serves as regulatory liaison to FDA /CDER/OPDP or FDA /CBER/APLB for assigned products, ... their aspirations. Join Kite and help create more tomorrows. **Job Description** Regulatory Affairs Advertising and Promotion (Ad/Promo) and Labeling is a core… more
- BeiGene (San Mateo, CA)
- …experience with interpretation and application to development projects and marketed product regulatory issues. + Demonstrated experience in effective ... **General Description:** + The Manager , Regulatory Affairs CMC, is responsible...collaborations partners and contract manufacturers. + Manage interactions with FDA and other global regulatory authorities for… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups. * Demonstrate proficient and ... Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US package and product ...and prepare regulatory labeling documents needed for regulatory labeling submissions. * Assist with FDA … more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology** will work on-site ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - Digital Health Technology**...requirements. **What You'll Work On** + Provides guidance on regulatory requirements and strategies to software product … more
- AbbVie (North Chicago, IL)
- …with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP). Qualifications ... execution of the regulatory strategy. 7. Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses… more
- dsm-firmenich (Princeton, NJ)
- …+ Contribute to the development of the NA regulatory strategy for new product innovations which will be led by manager . Support submissions related to OTC ... Regulatory Affairs Manager /Personal Care Princeton, NJ,... Regulatory Affairs Manager /Personal Care Princeton, NJ, US Hybrid Are you...import to Canada and USA, sunscreen drug listing at FDA and compliance with Proposition 65 and USP. +… more
- Philips (Cambridge, MA)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by ... & Diagnostics (AM&D) business group, including providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and… more
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