- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... rapport and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ colleagues regarding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Manager , Regulatory Affairs Labeling position will provide ... Degree in Life Sciences preferredExperience Qualifications4 or More Years direct regulatory affairs experience.4 or More Years in the biopharmaceutical… 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. 30% overnight ... within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Senior Manager of Medical Information Operations Excellence supports development, maintenance… 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)
- …stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy & Marketing, and the Global ... within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education… more
- Abbott (Abbott Park, IL)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Regulatory Affairs Manager ** **Working at Abbott** At Abbott, you ... blood disorders to infectious diseases and cancers. As the ** Regulatory Affairs Manager ,** you'll be... Affairs Associate Director. Additionally, you will provide regulatory support to ensure compliance with all FDA… more
- Evident Scientific (PA)
- …lives, together._** We are seeking a detail-oriented and experienced Senior Regulatory Affairs (RA) & Clinical Affairs Manager to join our team. ... FDA . This position requires a strong background in regulatory affairs , clinical trial management, and a...alignment with FDA , EU IVDR, and international regulatory requirements. + Act as the clinical affairs… more
- DEKA Research & Development (Manchester, NH)
- DEKA Research & Development has an immediate opening for a Regulatory Affairs Manager to contribute to a dynamic, medical device research and development and ... regulatory requirements are met throughout the development process. + Act as Regulatory Affairs SME during audits ( FDA , ISO, Supplier, Internal, etc.) +… more
- Abbott (Santa Clara, CA)
- …for the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Manager ** to join our team on-site in Santa ... will be recognized as an expert and resource in regulatory affairs for domestic and international filings....or clearance for division products as well as provide regulatory support to ensure compliance with all FDA… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage ... **Salary:** $130,000-160,000/year **Workplace:** Onsite in Seattle, WA **Overview** The Manager , Regulatory Affairs (CMC) is...support and guidance on CMC -related submissions to the FDA and other regulatory authorities worldwide. You… more
- Fujifilm (Santa Ana, CA)
- **Position Overview** We are hiring a Sr. Manager , Regulatory Affairs . The Sr. Manager , Regulatory Affairs will be responsible for ensuring that ... external and internal support as required. The Sr. Manager , Regulatory Affairs oversees and...therapies. The Company's facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines… more
- AbbVie (Mettawa, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion, combines ... pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (eg regulatory affairs fellowship, Health Authority, ad promo, etc.) + Preferred… more
- Olympus Corporation of the Americas (Westborough, MA)
- …entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Regulatory Affairs (RA) Program Manager Digital Strategy is responsible ... current and future products. This person will oversee collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- United Therapeutics (Research Triangle Park, NC)
- …lead projects supporting late phase drug development and marketing application submissions. The Regulatory Affairs Manager will function as the regulatory ... arterial hypertension (PAH **)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with...currently an option. **Who you are** You are a Regulatory Affairs professional looking to join a… more
- Olympus Corporation of the Americas (Westborough, MA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market Olympus ... and applicable supplements and annual reports and liaise with FDA reviewers as needed + Where designated, responsible for...of Olympus products in the EU. Interface with International Regulatory Affairs Team to support preparation of… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** ... do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at...Sr. management + Under general supervision, participate in core regulatory activities to ensure effective FDA interactions… more
- AbbVie (North Chicago, IL)
- …Advise internal cross-functional team who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs , Clinical Development, ... our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and Canada)...regulatory strategy. 7. Serve as HA liaison with FDA for routine communications in support of filings including… more
