- Novo Nordisk Inc. (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director. Works with personnel ... departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to… 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
- 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)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in...Nordisk portfolio. Relationships This position reports directly to the Sr . Director, Medical Affairs and will assist… 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
- Merck & Co. (Upper Gwynedd, PA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality activities… 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)
- …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 ... marketing analytics, TA marketing leads, Omni-Channel, product communications, medical affairs , market access and policy/advocacy (MAPA), and channel leads to… 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
- 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 ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of...associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to… 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
- Chiesi (Cary, NC)
- Ad Promo Manager , Americas Regulatory Affairs , Global Rare Diseases Date: Nov 2, 2024 Department: GRD Regulatory Affairs Job Type: Direct Employee ... Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary,... guidance documents that impact US activities related to Regulatory activities. + Interact with senior management,… more
- Insight Global (Florham Park, NJ)
- Job Description Insight Global is seeking a Sr . Manager of Regulatory Affairs to join one of our pharmaceutical clients in Florham Park, NJ. This ... for assisting with the development and execution of regional regulatory strategies for the Quality of Life (QOL) division....working with therapeutics and possesses a strong knowledge of regulatory requirements for Phase 1, 2, and 3. This… more
- Teleflex (MA)
- Sr . Regulatory Affairs Manager -...make a difference in patients' lives. **Position Summary** The Senior Manager , Regulatory Affairs ... technical files to design control and labeling reviews. The Senior Manager of Regulatory Affairs for Teleflex will lead regulatory strategies.… 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
- Bio-Techne (Minneapolis, MN)
- …Our family of brands creates a unique portfolio of products and services. POSITION SUMMARY The Regulatory Affairs Manager at R&D Systems will lead a team of ... Regulatory professionals, working closely with the Sr . Director, Regulatory Affairs and the R&D Systems (RDS) Quality Assurance team to ensure compliance… more
- American Heart Association (Washington, DC)
- …career. The **American Heart Association** has a phenomenal opportunity for an **Associate** ** Regulatory Affairs Manager ** with our Federal Advocacy Team in ... (hybrid work arrangements available. Under the direction of the Director, Federal Regulatory Affairs , you would be responsible for monitoring, analyzing, and… more
