- 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 sub ... 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 ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with CROs, License Partners, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …PCOR (Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs , and Legal & Compliance. External relationships ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare...NNI, a self-starter who is self-led and keeps their manager up to date on progress and ensures no… 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 ...and maintaining high performing teams both as a direct manager and a second line manager (ie,… 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
- Bausch Health (Bothell, WA)
- …creates itwhere your skills and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations ... + Act as the key liaison between the global regulatory affairs team and other departments, such...a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to… 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..., Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical … 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, ... will be hybrid in Mahwah, NJ or Weston, FL with some workplace flexibility. As the ** Manager , Regulatory Affairs ** , you will lead and coordinate global … more
- Olympus Corporation of the Americas (Westborough, MA)
- …. **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market Olympus medical devices in ... current, pending, and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry… 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 ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research &… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will work ... glucose levels with our new sensing technology. This **Senior Regulatory Affairs Manager - APAC**...for Diabetes care's projects. + Work closely with in-country regulatory representatives, compile, prepare, and review medical … more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an ... trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs , Advertising and Promotion is responsible… more
- TECO Energy (Tallahassee, FL)
- Title: ** Regulatory Affairs Manager ** Company: **Peoples Gas System** State and City: **Tallahasse, FL** Shift: **8 Hr. X 5 Days** **WHO WE ARE** Peoples Gas ... + Assist Governmental Affairs : Provide assistance to State Government Affairs by reviewing proposed legislation concerning regulatory policy and other… more
- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is...medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and… 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...PMA / IDE submissions + Experience with Class III medical devices + Ability to define regulatory … 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). ... be hybrid in Mahwah, NJ or Weston, FL with some workplace flexibility. As the **Senior Manager , Regulatory Affairs ** , you will lead and coordinate global … more
- Hologic (Marlborough, MA)
- Manager , Global Regulatory Affairs Marlborough,...+ A minimum of 8 years of experience in Regulatory Affairs within the Medical Device ... MA, United States The Manager , Global Regulatory Affairs will support leadership, ensuring alignment,...proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device or… more
