- 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
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for… 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 ... projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA...in Life Sciences preferredExperience Qualifications4 or More Years direct regulatory affairs experience.4 or More Years in… 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)
- …required4 or More Years Minimum of 3 years of experience in regulatory affairs requiredProject Management knowledge and certification preferredProven ability to ... around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager , Medical Review, will have responsibility for medical review within their ... Material Review Team (PMRT) and as a member of the Medical Affairs product team(s) for the assigned TA.Responsibilities- Ensure timely and comprehensive review… 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
- Aequor (Thousand Oaks, CA)
- …training within R&D. Experience in training within R&D. Background in clinical research, regulatory affairs , and research and development training in the biotech ... competency-based onboarding and upskilling support for staff in 's Regulatory Affairs and Safety organizations. The candidate will work with designated… 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)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... templates, reviews agreements, and manages outside counsel as necessary. Global Government Affairs Acts as legal advisor for Government Affairs groups within… 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 ... 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
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial Insights & Analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... and/or sales/operations experience required of which 2 years was in a manager role or equivalent Experience with patient support hubs, specialty pharmacies and/or… more
- Invenergy (Denver, CO)
- …be before or after the 3-day posting window. Job Description Position Overview The Manager /Senior Manager , Regulatory Affairs will represent Invenergy ... services, etc.) + Excellent verbal and written communication skills. Base Pay Manager , Regulatory Affairs : 125,000.00 - 150,000.00 USD Annual Bonus: 25% -… more
- System One (San Rafael, CA)
- Title of Position: Manager , Regulatory Affairs Location: San Rafael, CA Contractor Work Model (Onsite/Remote/Hybrid): Onsite Reason: Interim Worker to cover ... and providing personalized support and services globally. COMPANY Global Regulatory Affairs (GRA) is responsible for obtaining...the program teams on how best to interpret the regulatory legislation and guidelines. The Manager supports… more
- Chiesi (Boston, MA)
- Manager , Regulatory Affairs Operations, Rare Diseases Date: Jan 23, 2025 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... is Chiesi." **_Who we are looking for_** **Purpose** Currently seeking for a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience… 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 ... needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site...or law) preferred + 7 years pharmaceutical experience in Regulatory Affairs or related area + Experience… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager Regulatory Affairs US Advertising & Promotion, ... driver indications for a product and develops and supervises regulatory professionals as needed. The manager has...degree ) preferred. + 6 years pharmaceutical experience in Regulatory Affairs or relevant area + Experience… more
- Chiesi (Boston, MA)
- Manager , Regulatory Affairs Operations, Rare Diseases Date: Jan 10, 2025 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Boston, MA, US **_About us_** Based in Parma, Italy, Chiesi is an international… more
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