- AbbVie (Irvine, CA)
- …objectives, both strategic and applicable regulatory requirements. Director , Safety , Regulatory and Medical Affairs Quality Standards is responsible ... for the management of a RDQA global Safety , Regulatory Affairs (RA) and...role reports to the Senior Director of Safety , Vigilance and Medical Affairs Quality Assurance.… more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs -...**Overview** **THE ROLE:** Reporting to the VP of Global Regulatory & Post-market Safety Affairs , this ... implementation of strategy for multiple complex projects led by the corporate regulatory affairs team, including process improvement for efficiency gain,… more
- J&J Family of Companies (Plymouth, MN)
- Associate Director , Regulatory Affairs - 2406217663W **Description** **Johnson & Johnson** is currently seeking an **Associate Director , Regulatory ... understanding of the Medical Device industry. * Extensive training and education in Regulatory Affairs as related to worldwide product approvals. * A minimum… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... safety issues and product-associated events are reported to regulatory agencies. + Provide regulatory input for...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory ... regulatory team's engagement in evaluation of risk and safety issues for complex and/or critical products and recommends...Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Medical Device… more
- Stanford Health Care (Palo Alto, CA)
- …**A Brief Overview** The Senior Director of Quality Management and Regulatory Affairs is responsible for the strategic planning, oversight and direction ... of accreditation, regulatory , and licensing across Stanford Health Care. This includes...and care improvement committee responsibilities. Reporting to the Executive Director for Quality, Patient Safety & Infection… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …7 or More Years in the pharmaceutical industry preferred + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA preferred **Travel:** + Ability to ... via contact reports. + Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety ...all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Boston University (Boston, MA)
- As a pivotal leader within the Division of Student Affairs , the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large ... and multifaceted residential program. The Director provides strategic vision, leadership, and management to foster...Life program that aligns with the Division of Student Affairs ' mission, values, and strategic priorities. Ensure that all… more
- AbbVie (Mettawa, IL)
- …and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report ... in the pharmaceutical industry or academia or equivalent, with Global Medical Affairs experience highly preferred. Scientific Director + Advanced Degree PhD… more
- AbbVie (Florham Park, NJ)
- …and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation… more
- J&J Family of Companies (Cincinnati, OH)
- …with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & Compliance, Preclinical, Health ... Medical Director , Medical Affairs , Johnson & Johnson...leadership with product development, pre- and post-approval clinical studies, regulatory approval/clearance, downstream claims, safety assessments, and… more
- AbbVie (Waltham, MA)
- …product safety and risk management plans. Responsible for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report ... preferred. Will consider remote candidates. Purpose: The Associate Medical Director /Associate Scientific Director provides specialist medical/scientific strategic… more
- AbbVie (Mettawa, IL)
- …candidates. *Position title will be based on qualifications listed below. The Scientific Director for Medical Affairs in GI Care for exocrine pancreatic ... on time, on budget, and in compliance with AbbVie's policies and regulatory requirement. Qualifications Scientific Director Qualifications + Advanced Degree PhD,… more
- AbbVie (Florham Park, NJ)
- …and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and ... initiatives (medical education, data and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).… more
- AbbVie (Florham Park, NJ)
- …can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and ... scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of… more
- TXNM Energy (Albuquerque, NM)
- Executive Director , Public & Government Affairs Location: Albuquerque, NM, United States Job ID: 6088714 Date Posted:Sep 17, 2024 **JOB DESCRIPTION** **Executive ... Director , Public & Government Affairs ** Salary Grade:...SUMMARY: Under the guidance of the General Counsel, SVP Regulatory and Public Policy, directs policies and objectives involving… more
- Stryker (Fremont, CA)
- …external/internal sources and partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing to obtain ... link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Global Clinical Evidence and Medical Affairs **… more