- CorDx (Atlanta, GA)
- …some of the most critical questions in healthcare. Job Type: Full time Job Title: Senior Regulatory Affairs Manager Location: Onsite - Atlanta, or San Diego ... Position Summary: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical… more
- Stryker (Mahwah, NJ)
- …three days per week in Mahwah, NJ or Weston, FL. What you will do As the Senior Regulatory Affairs Specialist , you will support Stryker's Mako and Enabling ... Work Flexibility: Hybrid We are seeking a Senior Regulatory Specialist to join our...regulated industry 2+ years of experience in medical device regulatory affairs Thorough understanding of FDA, Europe,… more
- Lexington Medical (Bedford, MA)
- …of millions of patients worldwide and thrive in a growing company. We are seeking a Senior Regulatory Affairs Specialist to develop, lead and execute a ... product approvals and clearances. Qualifications: Bachelor's degree in Science, Engineering, Regulatory Affairs , or other technically related field. 5-8+ years… more
- Medtronic (Irvine, CA)
- …reports, and ensuring that our product technical documentation is current and accurate. SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR In the ... a more connected, compassionate world. A Day in the Life The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio.… 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 ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Fate Therapeutics, Inc. (San Diego, CA)
- Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of ... our corporate headquarters in San Diego, CA. Responsibilities Lead the Regulatory Affairs team in effectively working with internal and external stakeholders to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...health authorities.- Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory ...industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director, Policy. Other internal relationships include a dotted ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Katalyst HealthCares and Life Sciences (Irvine, CA)
- Responsibilities: Complete and maintains regulatory approvals/clearances of heart valve replacement and repair devices, Represent the Regulatory function on ... manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting requirements and resolving… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …in company projects, project-based tasks and/or special projects as assigned by the Senior Director, Regulatory Affairs . Additional duties related to ... have an exciting opportunity available for an Associate Director, Regulatory Affairs - Plasma Services in Boca...the needs of the business can be assigned by senior management as deemed necessary. Education Requirements: Bachelor's degree… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Central Garden & Pet (Dallas, TX)
- …application of department procedures/policies, etc.; and, other duties as required/requested by the Senior Director, FDA Regulatory Affairs & Food Safety ... has an exciting opportunity for a skilled and experienced Food Safety and Regulatory Affairs (FSRA) Manager to join our team! This position reports to the Sr.… more
- Betco Corporation, LTD (Bowling Green, OH)
- …development and present findings. Monitor, analyze, interpret and present information to senior management concerning regulatory affairs related to current ... sound product stewardship. Able to provide technical advice with respect to regulatory affairs to internal team members and our customers. Organize and maintain… more
- BioSpace (Indianapolis, IN)
- …over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing...knowledge and regulatory science expertise to drive regulatory CMC… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support the… more
- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the...and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops… more
- Merck & Co. (North Wales, PA)
- …resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research, and will support Pneumococcal Vaccines.Under the ... guidance of a senior leader, this position supports value evidence outcomes research...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and… more
