- 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)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… 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 for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director, Global Medical Affairs Training and Education is from… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site ... location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of… more
- Eisai, Inc (Nutley, NJ)
- …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 ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… 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, ... we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director...us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the… 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 ... lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of… more
- Kyowa Kirin North America (Princeton, NJ)
- …with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Regulatory Affairs , Advertising and Promotion ... for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director...with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of… more
- Katalyst HealthCares and Life Sciences (Columbia, MD)
- …functional project management. 4 years pharmaceutical experience including 1-2 years in regulatory affairs , R&D, or Manufacturing (CTD Module 3). May require ... Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group. Responsible for filing necessary applications and… 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
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewDedicated, knowledgeable, responsible/ reliable employee who can work in a fast-pace warehouse environment.… 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
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this ... and promotional materials for assigned products, submission of materials, and representing Regulatory Affairs on promotional review committee. Acts as primary… more
- Merck & Co. (North Wales, PA)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Organon (Plymouth Meeting, PA)
- …questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of ... Job Description The Position The Associate Principal Scientist ( Associate Director) is...Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned… more
- Soleno (Redwood City, CA)
- …solutions to the PWS community. Summary of Job (brief description) The Associate Director/Director, Medical Affairs Strategy and Strategic Operations will manage ... medical & scientific strategic and operational input into core medical affairs activities. Internally, the Associate Director/Director will work… more
- Servier (Boston, KY)
- …including regular partnership with US colleagues in Market Access, Communications, and Regulatory Affairs . The role will be responsible for monitoring and ... the focus of every strategic decision. Role Summary As a member of the Public Affairs and Policy team, the Assistant Director of Public Affairs & Policy is… more
