- Novo Nordisk Inc. (Plainsboro, NJ)
- …Internally, they may partner with the Local and Global Clinical Operations, regulatory affairs , medical affairs , legal, communications, compliance, etc. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... cross-functional teams, including analytics, therapeutic area marketing leads, sales, medical affairs , market access and policy/advocacy (MAPA), and channel leads to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... cross-functional teams, including analytics, therapeutic area marketing leads, sales, medical affairs , market access and policy/advocacy (MAPA), and channel leads to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... in the pharmaceutical or biotechnology industry (including minimum 2 years as a Senior Product Manager or equivalent) in positions of increasing strategic and… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research &… more
- United Therapeutics (Silver Spring, MD)
- …for cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with ... regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Sr. Manager of Regulatory Affairs , you will be responsible for supporting MMS Dispensing products consisting of Medical ... with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and… more
- AbbVie (North Chicago, IL)
- …products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- BeiGene (San Mateo, CA)
- **General Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent ... for development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet aggressive timelines. The individual will provide… more
- Teleflex (MA)
- …medical technology solutions that make a difference in patients' lives. **Position Summary** The Senior Manager , Regulatory Affairs is an experienced ... technical files to design control and labeling reviews. The Senior Manager of Regulatory Affairs for Teleflex will lead regulatory strategies.… more
- System One (Florham Park, NJ)
- Senior Manager , Regulatory Affairs (BRANDED PRODUCTS) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview ... The Contractor - Senior Manager , Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing … more
- Abbott (Santa Clara, CA)
- …lab results for millions of people. **What You'll Work On** We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory ... + Bachelor's Degree in life sciences, engineering, other technical discipline, or Regulatory Affairs + Minimum of 9 years of related work experience + Provides… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC ... degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in… more
- Amgen (Los Angeles, CA)
- …reach over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead ... **Live** What you will do Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at Amgen ensures the company's compliance with… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** Reporting to the Senior Manager , Regulatory Affairs , Microbiology, the Staff Regulatory Affairs Specialist is ... responsible for the preparation of strategies for moderately to highly complex regulatory submissions required to market new or modified medical devices and in vitro… more
- Medtronic (Lafayette, CO)
- …**Must-Have: Minimum Requirements** + Bachelors degree + Minimum of 7 years of regulatory affairs experience with 5+ years of managerial experience, or advanced ... + Directs or performs coordination and preparation of document packages for regulatory submissions from all company areas, internal audits, and inspections. + Leads… more
