- 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 ... technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.Health Authority Interactions: Leads US… 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
- Genmab (Plainsboro, NJ)
- … Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to ... degree from an accredited college of university Ten years' experience in pharmaceutical regulatory Technical system skills (eg Microsoft Word, ISI Toolbox, Veeva… more
- Larimar Therapeutics (Bala Cynwyd, PA)
- …consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs , and the development of manufacturing processes ... scientific leadership and a participatory workforce committed to success.Position:Senior Manager /Associate Director, Technical Operations Supply ChainPosition Summary:Reporting… more
- Atlas Data Systems (Wilmington, DE)
- …to drive decision-making and optimize launch plans. Collaboration with marketing, sales, regulatory affairs , medical affairs , and other departments is ... Job Description: We are seeking an experienced Senior Manager , Post Market Research, to lead and execute successful drug launches for top pharmaceutical clients. The… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose. The Role The Senior Statistical Manager supports the design, execution, analysis, interpretation, and reporting of clinical ... of data evidence for Clinical Research & Development and Medical Affairs programs with minimal supervision. This position supports statistical aspects of… more
- Larimar Therapeutics (Bala Cynwyd, PA)
- …consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs , and the development of manufacturing processes ... scientific leadership and a participatory workforce committed to success.Position:Sr. Manager /Associate Director, Quality, (Validation and Data Integrity)Reports to: Senior… more
- Fresno First Bank (Walnut Creek, CA)
- …and have a sense of urgency.About the Position: The Treasury Relationship Manager is responsible for developing new and existing deposit relationships for the ... Management systems and platforms.Maintains strong knowledge of risk management and regulatory compliance. Reinforces the application of superior customer service by… more
- Genmab (Plainsboro, NJ)
- …this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US Market and Commercial Teams (and others) and ... security architects and Genmab Security Operations Team Business leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM Genmab US) Peers within… more
- FirstEnergy Corp (Akron, OH)
- …Time Operations Energy Transactions, Metering and Support Systems and Rates and Regulatory Affairs . The group also occasionally participates in meetings ... PJM accounts is appropriate for the company - the PJM Company Account Manager (CAM) function. To accomplish these tasks, Regulated Settlements is responsible for… more
- General Dynamics Information Technology (Manassas, VA)
- …PKI and Identity Management policy development, technical liaison and advisor. HOW A REGULATORY AFFAIRS MANAGER WILL MAKE AN IMPACT * Provides ... 5 + years of related experience **US Citizenship Required:** Yes **Job Description:** Regulatory Affairs Manager Seize your opportunity to make a… more
- ThermoFisher Scientific (Fremont, CA)
- …regulatory compliance. * Implement policies, procedures, practices and strategies for Regulatory Affairs . * Collaborate with International RA, R&D, Marketing, ... and approve labeling, training, promotional, and advertising material. * Maintenance of Regulatory Affairs product files and ensure compliance with regulatory… more
- Medtronic (Boulder, CO)
- …in a more connected, compassionate world. **A Day in the Life** As the Regulatory Affairs Manager , you will be responsible for establishing strategy ... compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected...and coaching to specialists to meet schedules and resolve technical or operational problems. Becomes actively involved in daily… more
- AbbVie (Irvine, CA)
- …https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US ... in a scientific field, plus 6 years' experience in regulatory affairs ; or + Education equivalent to...such as regulations and guidance documents, as well as technical reports, in support of regulatory submissions.… more
- Philips (Hamilton, NJ)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and… more
- Ascendis Pharma (Palo Alto, CA)
- …perspectives to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and ... Alto, CA and reports directly to the Head of Regulatory Affairs . Key Responsibilities + Responsible for...impact of these requirements to the business. + Review technical documents and influencing colleagues across functions. + Must… more
- Harvard University (Cambridge, MA)
- …protected by law.Job Summary:The Senior Manager for Intergovernmental Policy and Regulatory Affairs for Harvard Public Affairs and Communications (HPAC) ... and its operations. The Senior Manager for Intergovernmental Policy and Regulatory Affairs brings significant knowledge of state and municipal regulatory… more
- ICU Medical (UT)
- Position Summary The Manager , Regulatory Affairs is a working Manager who assists in development and execution of Global Regulatory Strategies and ... and will not be discriminated against on the basis of disability. **Title:** * Manager , Regulatory Affairs - Electromechanical Devices - Remote* **Location:**… more
- ThermoFisher Scientific (Carlsbad, CA)
- …your career ambitions! **How will you make an impact?** Thermo Fisher is hiring a Regulatory Affairs Manager for in vitro diagnostics. They will provide ... in Carlsbad, CA, Frederick, MD, or Austin, TX. The manager will handle regulatory activities including drafting...**Experience:** + A minimum of 4 years within a technical environment; Regulatory Affairs , Quality… more
- Abbott (Princeton, NJ)
- …of our **Princeton, NJ** location in the Abbott Point of Care Division. As a ** Regulatory Affairs Manager ** , your role involves combining knowledge of ... regulatory input to product lifecycle planning. + Utilize technical regulatory skills to propose strategies on...is recognized as a discipline expert and resource in regulatory affairs . **Required Qualifications** + Bachelor's degree… more
