- Novo Nordisk Inc. (Plainsboro, NJ)
- …of any required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team ... for a living. Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical ... adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… 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)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products...seeks input and feedback from Area and National Account Manager team on tools, resources and systems that meet… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas during their rotations. Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, ... Essential Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs , Marketing, etc. This structured… 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
- 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)
- …Education throughout the one-year program. Additional key internal relationships include Medical Affairs , Marketing, Legal and Regulatory Affairs . Other ... internal relationships include managed care, trade, government affairs and global marketing.External relationships include relations with key opinion leaders,… more
- American Honda Motor Co Inc (Torrance, CA)
- …of 8 years of experience in the energy industry with a strong focus on regulatory affairs and advocacy is required.* A proven track record of successfully ... teams have a clear understanding of their compliance obligations while advocating for regulatory changes that enable the delivery of new products and services that… more
- Merck & Co. (Rahway, NJ)
- …learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements. The ability to multi-task, work independently, ... and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, and resource allocation… more
- Exact Sciences (Boston, MA)
- …with a range of internal stakeholders including Screening Advocate (SA), Medical Affairs and Marketing. Inform, educate and enable target physician and stakeholder ... range of internal cross-functional stakeholders, including Account Managers, Area Manager , Marketing, Sales Operations and Internal Sales Support. Communicates a… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies ... Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is committed to equality of opportunity in… more
- Novo Nordisk (Princeton, 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 applications (IND,… more
- Englewood Lab, Inc (Totowa, NJ)
- Reports to: Manager of Regulatory Affairs Responsibilities: + Assist the Manager of Regulatory Affairs during cGMP, Environmental, and ... direct supervision of the Head of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates,… more
- AbbVie (Irvine, CA)
- …https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US ... to a BS degree in a scientific field, plus 6 years' experience in regulatory affairs ; or + Education equivalent to a MS degree in a scientific field, plus… more
- ThermoFisher Scientific (Greenville, NC)
- …a crucial role in the development of novel and innovative medical devices?** The Regulatory Affairs Manager develops regulatory strategies and supports ... of products, as well as the preparation of marketing applications. The Regulatory Affairs Manager identifies and communicates potential risks and mitigations… more
- ADM (Kennesaw, GA)
- **83651BR** **Job Title:** Senior Regulatory Affairs Manager **Department/Function:** Legal, Compliance, Regulatory Affairs , Corporate Security **Job ... This is a full-time, exempt level position. **Position Summary:** The Senior Regulatory Affairs Manager is responsible for the assessment of regulatory… more
