- 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
- 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
- Intuitive (Sunnyvale, CA)
- …working experience supporting international submissions preferred; Previous China regulatory affairs experience is a major plus. Demonstrated understanding ... (PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted accurately, ethically based upon… 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
- Katalyst HealthCares and Life Sciences (Boston, MA)
- Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international ... 3 days per week) based in Marlborough, MA. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and… more
- Cedent (Boston, MA)
- As a Clinical Trial Regulatory Affairs Specialist, you will be responsible for: * Regulatory Compliance: Ensuring all clinical trials adhere to applicable ... 4. What We're Looking For *Experience: A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement… more
- Boston Scientific (Irvine, CA)
- …Urology solutions. We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active ... implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing... strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged… 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
- 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
- Calyxo (Pleasanton, CA)
- …team working in a fun, diverse atmosphere. Summary: As a key member of the Regulatory Affairs team, you will play a vital role in ensuring compliance with ... regulatory authorities. Your knowledge of domestic and international regulatory requirements will help guide internal...Arena etc. required. Who You Will Report To: Director, Regulatory Affairs Requirements: 5+ years of … more
- U-Haul (Phoenix, AZ)
- …educational experience. Experience: 1-2 years of experience in insurance compliance, regulatory affairs , actuarial support, or operations (Med Supp experience ... 2721 N Central Ave, Phoenix, Arizona 85036 United States of America he Regulatory Compliance Analyst supports the Compliance, Actuarial, and Finance teams in the… more
- American International Group, Inc. (New York, NY)
- …your browser: http://www.phila.gov/HumanRelations/PDF/BTB%20POSTER%20FINAL_3-9-16.pdf Functional Area: LG - Legal, Regulatory & Gov't Affairs AIG PC Global ... attorneys and other professionals providing high quality advisory, transactional and regulatory support across GI on ceded and assumed reinsurance-related matters… more
- Republic Services (Detroit, MI)
- …Performs tasks as diverse as document management, coordination of meetings for large regulatory projects. Supports the Regulatory Affairs management in ... organizational and communication skills. Working knowledge of US, Canadian or international regulatory guidelines. MINIMUM QUALIFICATIONS: 2 years of experience… more
- ADC Therapeutics SA (New Providence, NJ)
- …Development, GMP Quality Assurance, Biostatistics, Pharmacovigilance, Clinical Supply Chain, Regulatory Affairs , Legal, and Executive Leadership to support ... and CAPA Effectiveness. * Regulatory Strategy and Compliance: Collaborate with regulatory affairs and clinical operations to align quality assurance… more
