- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead… more
- 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 headquarter departments to accomplish company goals.… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Aequor (Thousand Oaks, CA)
- …Functional areas, internal and external to GRAAS, local offices, external partners, and regulatory authorities. This will be a 100% remote role. The hiring ... manager confirmed they are looking for someone who works...PST time zone. The type of qualities/characteristics the hiring manager is looking for in candidates that will work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence,… more
- Aequor (Thousand Oaks, CA)
- …supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research, ... FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for… more
- Aequor (Thousand Oaks, CA)
- …time. Ideal candidate: In need of 5-8 YOE in project management within R&D and regulatory affairs , within pharmaceutical. Not a tech expert but they need to ... technology development. Enterprise level engagement. Job Title: Senior Project Manager - End to End Regulatory Content...to End Regulatory Content Automation Initiative, Global Regulatory Affairs and Strategy, Position Summary: We… 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 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… more
- Merck & Co. (Rahway, NJ)
- …with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs , Global Medical and Scientific Affairs to ... Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or… more
- Merck & Co. (Rahway, NJ)
- …payment timelines.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... to make decisions independently with limited oversight from Sr.COM or manager .Requires strong understanding of local regulatory environment.Ability to… more
- Catalent (San Diego, CA)
- …food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... ensuring consistent quality standards are maintained. Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… 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-level marketing ... cross-functional teams, including analytics, therapeutic area marketing leads, sales, medical affairs , and channel leads to align marketing tactics with overall… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & Marketing, and Legal ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including but not limited investor relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful ... candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree in relevant discipline required Experience Qualifications- 4 or More… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Paid Media, Medical, Managed Markets, Corporate Communications and Public Affairs , Regulatory , Privacy, Sales, and Legal. Will also interact ... content management functions for all NNI internet sites Manage PRB (medical, legal, regulatory ) review of NNI internet site and its waterfall of content Manage… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management ... (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory… more
- Amgen (Washington, DC)
- …do your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Affairs Manager - Regional Regulatory Lead** ... role you will achieve the desired labeling by developing and implementing US regulatory strategies. **Responsibilities:** + Implement the US regulatory plan and… more
- Constellation (Washington, DC)
- …comprehensive benefits package that includes bonus and 401(k). **Job description for Sr. Manager , Federal Regulatory Affairs and** **Director, Federal ... Regulatory Affairs listed below:** **Sr. Manager Federal Regulatory Affairs ** **Primary Purpose of Position** The position develops, advocates and… more
