- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager Regulatory Affairs Strategic Labeling , develops and maintains US/EU ... data is included as support documentation following approvals. Provides labeling input for Risk Management Plans, Regulatory ...accurate safety profiles for assigned products. + Works with Labeling Operations to ensure quality documents are… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12152BR** **Title:** Intern, Regulatory Affairs **Job Description:** Are you interested in working for an organization that is making a difference in people's ... closer look at what MicroVention(R) TERUMO has to offer. Regulatory Affairs (RA) Intern The Regulatory...or Health Canada) + Partner and collaborate with R&D, Operations , Quality, Labeling , and Marketing to help… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory affairs ... with the commercial needs. + Communicates planned/approved changes with operations , commercial, medical affairs , and marketing. +...in a scientific field, plus 6 years' experience in regulatory affairs ; or + Education equivalent to… more
- Teleflex (Maple Grove, MN)
- Sr. Regulatory Affairs Specialist **Date:** May 12, 2024 **Location:** Maple Grove, MN, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** ... solutions that make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and submissions for projects… more
- Astellas Pharma (Northbrook, IL)
- …elevated to upper management for further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that contents ... are consistent with the current approved US Prescribing Information and advises Regulatory Operations group regarding requirements for FDA 2253 submissions.… more
- Merck (Rockville, MD)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... **Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:** +...Product Development Team (PDT), Early Development Team (EDT), and Labeling Working Groups). + Participate in regulatory … more
- Abbott (Alameda, CA)
- …with our new sensing technology. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist,** as part of the Regulatory Affairs ... CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support...but may consider quality assurance, research and development/support, scientific affairs , operations , or related area. + Communicate… more
- Teleflex (Wyomissing, PA)
- Sr. Regulatory Affairs Specialist **Date:** May 28, 2024 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... healthcare. For more information, please visit **teleflex.com** . **Global Operations -** Global Operations is a complex...a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US,… more
- Colgate-Palmolive (Topeka, KS)
- …and join our global team! **Join Our Pack and Uphold Hill's Mission as a Regulatory Affairs Specialist!** Are you committed to ensuring that every pet receives ... pets and their owners through quality nutrition. As a Regulatory Affairs Specialist, you'll play a pivotal...ensuring consistency and compliance across all aspects of our operations . + Monitor and maintain records related to ingredients… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist II - APAC** will work out of our ... team goals and division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution of compliance issues,… more
- Bausch Health (Bothell, WA)
- …care options to consumers and physicians alike. The Manager, Regulatory Affairs provides direct support to Solta operations for their globally distributed ... Provides regulatory expertise to the R&D and Operations teams, including labeling requirements and submission...Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience… more
- Abbott (Austin, TX)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist II** position will work on-site out ... team goals and division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution of compliance issues,… more
- ICL (St. Louis, MO)
- Regulatory Affairs Intern or Co-op Date: May 17, 2024 Posting End Date: Location: St. Louis, MO, US, 63141 Company: ICL Americas LLC This position provides ... functioning as part of the global HERA (Health, Environmental, Regulatory Affairs ) shared service. The primary support...regulatory and technical documents, safety data sheets and labeling . + Actively participates in the new / revised… more
- Edwards Lifesciences (Irvine, CA)
- …. **How you will make an impact:** As a Senior Specialist, International Regulatory Affairs , you complete and maintain regulatory approvals and ... us achieve our goals:** + Experience with strong input/authoring 510(k)s + Regulatory affairs experience with software devices and product development **What… more
- Edwards Lifesciences (Irvine, CA)
- …. **How you will make an impact:** As a Manager, Regulatory Affairs , you are responsible for completing and maintaining ... regulatory approvals and clearances of assigned products. + Representing the regulatory function on manufacturing and product development teams as a subject… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... on utilizing regulatory updates to expedite approval process * Review labeling content product and process changes, and product documentation to assure … more
- Gilead Sciences, Inc. (Foster City, CA)
- …and distributed. + Serves as a labeling and artwork resource for Regulatory Affairs , Legal, Graphic Design, Package Engineering, and Quality Assurance. + ... improve life by advancing the care of patients with life-threatening diseases. Labeling Project Coordinator II, Labeling Operations **Job Responsibilities**… more
- Pfizer (San Diego County, CA)
- …Labeling Justification Document/Clinical Overview author) and will provide day-to-day direction to Labeling Operations Managers so that labeling can be ... Medical, and other cross-functional SMEs) + GLLs partner with Labeling Operations Managers as well as ...Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …, Strategic Operations , Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device Engineering, ... for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the… more