- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with CROs, License Partners, ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Merck & Co. (North Wales, PA)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and...and maintaining high performing teams both as a direct manager and a second line manager (ie,… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs ( RA ) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy ... project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions...planning activities and FDA communications. Associate Director Act as Regulatory Affairs ( RA ) core or… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an onsite ... Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is...discipline. + Advanced degree or additional professional training in regulatory affairs ( RA ) desired. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and Promotion ( RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and...working with external operational contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Stryker (Shirley, MA)
- We are currently seeking a ** Manager , Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, ... or Weston, FL with some workplace flexibility. As the ** Manager , Regulatory Affairs ** , you...divisions. You will confidently and collaboratively work across the RA teams and cross-functional partners, as well as with… more
- AbbVie (Waltham, MA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ... documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA... affairs department. Participates in initiatives internal to RA CMC. Represents CMC regulatory affairs… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to ... ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**...|| United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA… more
- Envista Holdings Corporation (Brea, CA)
- …claims and literature. + Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs . + Assists with Customs requests. + ... **Job Description:** The ** Regulatory Affairs Specialist** is responsible for...PMS reports. + Works in partnership with manufacturing and RA /QA in designing and enhancing quality management systems to… more
- Stryker (Weston, FL)
- We are currently seeking a **Senior Manager , Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). ... Weston, FL with some workplace flexibility. As the **Senior Manager , Regulatory Affairs ** , you...divisions. You will confidently and collaboratively work across the RA teams and cross-functional partners, as well as with… more
- Teva Pharmaceuticals (West Chester, PA)
- Director, Regulatory Affairs - Dossier Project Manager Date: Jul 19, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... Project Manager , a key member of Global Regulatory Affairs , will be responsible to develop...and expedite critical path deliverables, and orchestrate hand-offs to Regulatory Operations or the local International Market RA… more
- Bausch Health (Bothell, WA)
- …creates itwhere your skills and values drive our collective progress and impact. The Manager , Regulatory Affairs will be responsible for: + Responsible for ... and product marketing strategy for product portfolio which been assigned. + Regulatory affairs professionals actively participate on NPI (new product… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager Regulatory Affairs , Advertising and Promotion will oversee therapeutic ... The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC** position will work closely with in-country… more
- Medtronic (Santa Rosa, CA)
- …we work together to engineer the extraordinary. Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and ... will be based in Santa Rosa, CA. The **Principal Regulatory Affairs Specialist** will support Research and...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Arkema (Radnor, PA)
- … regulatory issues pertaining to each BU and its products. (5%) + Support Manager , Product Stewardship & Regulatory Affairs in efforts to effectively ... Sr Product Stewardship & Regulatory Affairs Specialist Job Location: Radnor,...effective and efficient manner. This position reports to the Manager , PS& RA for the Specialty Surfactants BU… more
- Medtronic (Minneapolis, MN)
- …engineer the extraordinary. This role will be based in Plymouth, MN The ** Regulatory Affairs Specialist** is responsible for developing regulatory ... submissions and obtaining and maintaining approval for products. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device… more
- Abbott (Plymouth, MN)
- …people to restore their health and get on with their lives. **The Opportunity** The Regulatory Affairs Manager will work on-site at our Plymouth, MN location ... for our Electrophysiology division. As a manager , the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and… more
