- Leica Biosystems (Miami, FL)
- …Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution ... interactions to secure product approvals.Collaborate cross-functionally and globally with Clinical Affairs , R&D, QA, and Business Development to align regulatory… more
- BlueRock Therapeutics (Cambridge, MA)
- …lives. In this newly created and highly visible role reporting to the Head of Development , the Head of Medical Affairs will have the unique opportunity to build ... Cambridge, MA. Responsibilities: Create and implement a Vision for BlueRock's Medical Affairs & Scientific Communications Build and provide leadership to key Medical… more
- EBR Systems, Inc. (Sunnyvale, CA)
- …for 1-2 years of experience. Minimum of 5 years of regulatory affairs experience, including post-market and sustaining activities. International experience in ... Affairs Specialist Basic understanding of US FDA and international regulatory requirements. Experience supporting regulatory submissions under supervision. Strong… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. ... Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative,… more
- Abbott (Santa Clara, CA)
- …be your true self and 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 ... in regulatory preferred but may consider quality assurance, research and development /support, scientific affairs , operations, or related area. Ability to… more
- Katalyst HealthCares and Life Sciences (Baltimore, MD)
- …regulatory guidance and RA strategies. Excellent knowledge of US and European/ International regulations and standards. RAPS' Regulatory Affairs Certification ... to ensure global success of products' registration. Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and… more
- Katalyst HealthCares and Life Sciences (Southern Md Facility, MD)
- …applicable regulations. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the ... development team. Provides guidance and expertise. Review and evaluate...the FDA or other worldwide regulatory agencies to various international affiliates. Maintains pertinent domestic and international … more
- Abbott (Alameda, CA)
- …be your true self and 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. ... mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our Alameda, CA, location in… more
- EPM Scientific (Bridgewater, MA)
- …leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to support regulatory development and post-approval compliance for a ... and device categories. Serve as a regulatory lead on cross-functional product development and life-cycle management teams. Ensure timely and accurate preparation of… more
- Kyowa Kirin North America (Princeton, NJ)
- …7+ years of pharmaceutical experience. Broad understanding of pharmaceutical development , Regulatory Affairs , Quality Assurance, Safety and Commercial. ... adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton,… more
