- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… more
- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director, Global Medical Affairs Training and Education… 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 ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Eisai, Inc (Nutley, NJ)
- …strategic imperatives for assigned therapeutic area(s). Collaborate with other stakeholders across Global & US Medical Affairs functions and regions, in addition ... a difference. If this is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for the strategic planning and… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. ... love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and execution ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management Develop and execute… more
- Merck & Co. (North Wales, PA)
- …BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction ... marketing of medical drugs and vaccines for the benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics,… more
- Liberty Utilities Co. (Litchfield Park, AZ)
- …regulated utilities in the West region. This position is responsible for all regulatory affairs and rates related functions in multiple jurisdictions. The ... witness on rate and regulatory related filings at the local regulatory commissions. Manages the development of strategies associate with revenue… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our ... New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic… more
- Seaport Therapeutics (Boston, MA)
- …degree required; advanced degree in a scientific discipline preferred. 10+ years in global regulatory affairs with including expertise in early development ... please visit www.seaporttx.com. Position Summary: We are seeking a strategic, hands-on Associate Director OR Director, Regulatory Affairs to lead… more
- AbbVie (North Chicago, IL)
- … compliance, and contributes to the overall success of drug/device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the ... R&D Quality Medical Affairs (MA) QA team which provides independent quality oversight...Responsibilities: Contribute to a state of continuous compliance with global regulations, AbbVie policies and procedures and regulatory… more
- CorDx (Atlanta, GA)
- …of the most critical questions in healthcare. Job Type: Full time Job Title: Associate Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position ... Summary: The Associate Regulatory Affairs Manager will...projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate … more
- GRIFOLS, SA (Clayton, NC)
- …of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the ... Affairs Specialist I Primary responsibilities for role: Act as Regulatory Affairs representative for specified key products/facilities/equipment. Prepare… more
- IQVIA, Inc. (Durham, NC)
- …( Associate ) Director will play a critical role in supporting the Regulatory Affairs and Drug Development Solutions (RADDS) team-not through direct sales, ... with its customers and partners. The Research and Development Solutions Global Business Unit is dedicated to transforming clinical development through intelligent… more
- Actalent (Winston Salem, NC)
- …initiatives. Collaborate closely with cross-functional teams, including Quality Assurance, Regulatory Affairs , and Manufacturing, to ensure successful transfer ... Job Title: Research Associate Job Description We are currently seeking an...and validation of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards. Conduct process performance qualification… more
