- Parexel (Des Moines, IA)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs ... professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior … more
- GRAIL (Olympia, WA)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- ITG Brands (Greensboro, NC)
- …evolving FDA guidance and behavioral science methodologies to inform regulatory strategy and study design. Provide expert consultation to internal teams on ... leadership in designing and managing studies that address complex behavioral and regulatory questions. Direct experience with FDA 's regulatory framework,… more
- ITG Brands (Greensboro, NC)
- …hold these certifications should be willing to obtain them. In-depth knowledge of FDA regulatory pathways, especially PMTA and SE submissions. Proven ability to ... WILL DO Lead the development of toxicology strategies for PMTA and other regulatory submissions, ensuring alignment with FDA expectations and public health… more
- Endo International (St. Louis, MO)
- …of manufacturing sites in the area of Quality Systems, and Training. + Interfaces with FDA and regulatory agencies outsite the US for events that include but are ... for pharmaceutical products and medical devices. + Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection… more
- BeOne Medicines (Pennington, NJ)
- …drug preclinical, clinical and commercial requirements. + Familiarity with EMA and FDA regulatory requirements for submissions. + Effective communication, oral ... with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory , Process Development groups and MST counter parts located in… more
- Lundbeck (Deerfield, IL)
- …for a rare disease + Past responsibility for managing IIT process + FDA regulatory knowledge and direct exposure **TRAVEL:** + Willingness/ability to travel ... Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory , Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific… more
- Lundbeck (Deerfield, IL)
- …for a rare disease. + Past responsibility for managing IIT process. + FDA regulatory knowledge and direct exposure. **TRAVEL:** + Willingness/ability to travel ... Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory , Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific… more
- Lundbeck (Deerfield, IL)
- …sciences + Masters. Doctorate Degree or MBA, other professional certifications. + FDA experience + Exposure to international regulatory affairs, including ... Director US Regulatory Strategy Requisition ID: 7214 Location: Deerfield, IL,...support investigational and marketing registration packages for the US FDA . + Liaises with FDA as needed… more
- Parexel (Hartford, CT)
- …related industry experience. - Direct experience in advertising and promotional regulatory review. - Familiarity with FDA regulations governing promotional ... timelines. - Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional… more
