- Chiesi (Boston, MA)
- …Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... departments to ensure product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate. + Review and… more
- Roche (Indianapolis, IN)
- …be working closely with colleagues in other departments and other counties. As a Regulatory Affairs Manager focused on Companion Diagnostics (CDx), with ... love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the...have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior 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
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …local market authorization holders and distributors. **Primary Responsibilities:** + Act as Regulatory Affairs authority for key product registrations with a ... with regulatory authorities. + Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory … more
- Reckitt (Parsippany, NJ)
- RAS ( Regulatory Affairs Safety) Strategy Manager , Specialty & Allergy City: Parsippany **We are Reckitt** Home to the world's best loved and trusted hygiene, ... of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager , Clinical Research Regulatory Affairs is tasked ... with oversight and governance of Regulatory Affairs department and involved in the day-to-day support of the clinical research studies conducted at Children's… more
- Abbott (Livermore, CA)
- …their lives. This position leads payor relations (including payor contracting) and regulatory affairs , which are foundational functions to driving ongoing ... live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify… more
- Medtronic (Santa Rosa, CA)
- …to engineer the extraordinary. **Role and Responsibilities** + Team with operating unit Regulatory Affairs Specialists and international regulatory staff ... Mounds View, MN or Santa Rosa, CA. The **Senior** ** Regulatory Affairs Specialist** will support our innovative...agency personnel. + Assist in negotiations with FDA and/or international regulatory agencies on assigned projects/products. +… more