- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... maintains constructive and positive interactions with colleagues. Essential Functions Therapeutic Area: Assist Manager /Director in review of labeling for… more
- Merck & Co. (North Wales, PA)
- …this experience is in regulatory affairs .Required Experience and Skills: Regulatory experience preferred for therapeutic area experience in vaccine or ... Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for...their assigned projects in the Vaccines and Infectious Disease therapeutic area.The selected individual will function with a high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …throughout NNI and at external agencies. Key relationships include Marketing, Legal, Regulatory Affairs , and Medical Affairs . Other relationships may ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...when applicable Work with the Medical Director in Medical Affairs for the assigned product(s)/ therapeutic area(s) to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...expert for our products and related data within a Therapeutic Area (Diabetes-GLP-1, Diabetes-Insulins, Cardiorenal Diseases, Obesity, NASH, Rare… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain… more
- J&J Family of Companies (Raritan, NJ)
- Manager Global CMC Regulatory Affairs...regulatory strategy is aligned with strategies of global regulatory Affairs , therapeutic areas and ... Johnson & Johnson Innovative Medicine is recruiting for a Manager , CMC Regulatory Affairs to... regulatory strategy through partnership and communication with Therapeutic Area Regulatory affairs +… more
- AbbVie (Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs In Vitro Diagnostics and Companion ... implements, and documents policies and procedures within the regulatory affairs department under supervision of manager . Participates in initiatives internal… more
- CSL Behring (King Of Prussia, PA)
- …market biotherapies used to treat serious and often rare conditions. Could you be our next Manager of Global Regulatory Affairs ? The job is located in the ... a hybrid position. You will report to the Regional Regulatory Therapeutic Area Director Lead. **Responsibilities:** +...Lead. **Responsibilities:** + You will plan, direct, and monitor regulatory affairs activities so we have the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Vendor Governance is a function within the RA Business ... and overall success of the vendor partnerships utilized by Regulatory Affairs . Gilead Sciences is seeking an...to resolve + Maintains knowledge of company disease and therapeutic areas + Has an appropriate level of IT… more
- Merck (North Wales, PA)
- …is in regulatory affairs . **Required Experience and Skills:** + Regulatory experience preferred for therapeutic area experience in vaccine or infectious ... **Job Description** The Director, Regulatory Affairs Liaison, is responsible for...their assigned projects in the Vaccines and Infectious Disease therapeutic area. The selected individual will function with a… more
- Bausch Health (Bothell, WA)
- …care options to consumers and physicians alike. Reporting to the Sr. Director, Global Regulatory Affairs , the Senior Manager , Regulatory Affairs ... technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been...globally distributed products. This role is not a regional regulatory but global regulatory position which under… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located in our ... commercialization. + Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the… more
- Bausch Health (Bothell, WA)
- …proven and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations ... technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been...Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience… more
- AbbVie (South San Francisco, CA)
- …to meet relevant regulatory HA requirements. + Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic ... internal cross-functional team who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, &… more
- AbbVie (Lake Bluff, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - Combination Products and ... a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care...trends and best practices in combination product and device regulatory affairs , review and comment on changing… more
- Sanofi Group (Bridgewater, NJ)
- …experience in the following areas: + Experience within pharmaceutical or medical device Regulatory Affairs . + Successful track record with ideally 1-3 years ... **Position Overview:** With minimal direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …core values by staying **True to Life.** **Job Description** The Specialist I - Regulatory Affairs will support the maintenance of EU MDR technical documentation ... and conduct other elements of sustaining Regulatory Affairs including maintaining "state of the art". In addition, this position will support the regulatory … more
- Novo Nordisk (Princeton, 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
- AbbVie (Chicago, IL)
- …or Industry-related experience. + Preferred Experience: 5 years in pharmaceutical regulatory affairs . + Demonstrates effective communication skills in written ... has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director),… more
