- GRAIL (Atlanta, GA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... 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)
- …tobacco and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and ... regulatory industry (tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state- regulatory compliance, regulatory… more
- Terumo Neuro (Aliso Viejo, CA)
- …for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing,...technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU… 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
- 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
- Parexel (Salem, OR)
- …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
- Endo International (Hobart, NY)
- …of work or the Quality Culture at the site. + Extensive knowledge of FDA regulatory requirements applicable to pharmaceuticals. Applies GMP regulations and other ... Challenges the way it has always been done. Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality… more
