- 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)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Managed Markets, Legal, Compliance, and Finance. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Beckman Coulter Diagnostics (Miami, FL)
- …be a part of the Global Process Owner (GPO) Team and report to the Senior Manager of Global Quality responsible for overseeing various Global Quality Management ... tools that address the world's biggest health challenges. The Senior Staff Global Process Owner (GPO) Quality Assurance for...not required but training and certificates in quality or regulatory affairs would be a plus (eg… more
- Aldevron (Miami, FL)
- …that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation and will be responsible for representing the Analytical… more
- Invenergy (Denver, CO)
- …or after the 3-day posting window. Job Description Position Overview The Manager / Senior Manager , Regulatory Affairs will represent Invenergy before ... Affairs : 125,000.00 - 150,000.00 USD Annual Bonus: 25% - 40% Senior Manager , Regulatory Affairs : 145,000.00 - 165,000.00 USD Annual Bonus: 25%… more
- Abbott (Atlanta, GA)
- …diversity, working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Senior Manager Regulatory Affairs ** to join Abbott's ... new team member is responsible for the management and leadership of the Regulatory Affairs department. The manager is responsible for allocating and managing… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you will help develop ... either Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx Regulatory in cross-functional teams… more
- Liberty Utilities (Merrick, NY)
- Senior Manager , Rates and Regulatory Affairs Merrick, NY, US, 11566 **Our purpose is sustaining energy and water for life, and it is demonstrated in ... the goal outcome and how we achieve it.** **Purpose** The Senior Manager Rates and Regulatory Affairs is responsible for all regulatory affairs … more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Senior Manager , International Regulatory Affairs , you will be responsible for Central Asia, South Asia, and Japan (CASAJ) ... are met. **About You:** + Minimum BA/BS required. + Minimum 8 years regulatory affairs experience; or a combination of regulatory affairs , quality… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include… more
- Abbott (Santa Clara, CA)
- …Our location in Santa Clara, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve ... trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals...Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising ... Supports the Director/Associate Director in efforts to influence the regulatory environment. The Senior Manager ...pharmacy) plus 7 years of relevant industry experience (eg regulatory affairs fellowship, Health Authority, ad promo,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... with colleagues across the global RA CMC organization, Gilead regulatory affairs , and affiliates on internal meetings and Health Authority interactions.… more
- Medtronic (Mounds View, MN)
- …in a more connected, compassionate world. **A Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute ... + Provide business and product information to the international regulatory affairs team to enable development and...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Medtronic (Mounds View, MN)
- …to innovation in a more connected, compassionate world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key role in ... develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior... regulatory requirements and partners with the international regulatory affairs group to support regulatory… more
- Bausch Health (Bridgewater, NJ)
- …creates it-where your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… 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 ... As a manager , the function of a Manager Regulatory Affairs is to...outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …to join us in this mission? Kite, a Gilead company is hiring a ** Senior Medical Manager ** to support US Medical Affairs . As a Senior Medical Manager , ... information and stays informed on scientific trends and competition. **Position Overview:** The Senior Medical Manager , Medical Affairs , will play a key… more
