- L'Oreal (Clark, NJ)
- …and experiences that will change people's lives. As a Principal Scientist, Scientific & Regulatory International Affairs (SRIA) Americas in Regulatory ... strategic initiatives. International activities: Collaborate with trade associations' international regulatory groups (eg, PCPC) to enhance awareness, ensure… more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... License Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global ... Medical Affairs /MSL training and continued education plans related to Eisai's...credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical… more
- Medtronic (Irvine, CA)
- …for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. ... with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… 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. (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 ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and may… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (Rahway, NJ)
- …is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/ international regulations as they ... an effective Industrial QMS that provides compliance to relevant international standards, customer requirements and regulatory requirements.Maintains oversight… 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 ... located at our corporate headquarters in San Diego, CA. Responsibilities Lead the Regulatory Affairs team in effectively working with internal and external… more
- Betco Corporation, LTD (Bowling Green, OH)
- Develop, implement and coordinate compliance with federal, state, local and international regulatory requirements applicable to Institution cleaning chemicals, ... stewardship. Able to provide technical advice with respect to regulatory affairs to internal team members and...Compliance on labels and (M)SDS's according to US and International requirements. Monitor activities at the federal, state and… more
- Stryker (Mahwah, NJ)
- …regulated industry 2+ years of experience in medical device regulatory affairs Thorough understanding of FDA, Europe, and international medical device ... in Mahwah, NJ or Weston, FL. What you will do As the Senior Regulatory Affairs Specialist , you will support Stryker's Mako and Enabling Technology portfolio new… more
- Lexington Medical (Bedford, MA)
- …of patients worldwide and thrive in a growing company. We are seeking a Senior Regulatory Affairs Specialist to develop, lead and execute a regulatory ... product approvals and clearances. Qualifications: Bachelor's degree in Science, Engineering, Regulatory Affairs , or other technically related field. 5-8+ years… more
- BioSpace (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Capstan (Santa Cruz, CA)
- Reports to: Head of Regulatory Affairs (SVP, RA) Workplace type: Hybrid Description: This is a unique opportunity for an experienced Regulatory Affairs ... positioned to revolutionize structural heart care. The Manager of Regulatory Affairs will help build and execute...PMAs, etc.) in collaboration with the team. Work with international affiliates to compile and submit international … more
- Johnson and Johnson (Raynham, MA)
- …SUPPORT Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Affairs - MD Job Category:… more
- Cleerly (Denver, CO)
- …be listed as requirements in the job description. About the Opportunity As Principal Regulatory Affairs Specialist, you will provide regulatory support and ... or higher degree in a Life Science, Engineering or related discipline. Regulatory Affairs Certification (RAC) preferred. Demonstrated knowledge and experience in… more
- IntePros (Audubon, PA)
- IntePros is currently looking for a Regulatory Affairs Associate to join one of our growing Medical Device clients in Audubon, PA. The Regulatory Affairs ... Associate maintains CE Technical Files and registrations for international Regulatory agencies. This position entails working knowledge of products under review… more
