- 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
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine… more
- Kyowa Kirin North America (Princeton, NJ)
- …NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs , Advertising and Promotion ... ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA Form 2253… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and… more
- Genmab (NJ)
- …to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and ... in alignment with overall business objectives. Relationships Reports to the Sr. Director , Wegovy Consumer Marketing . C ollaborates with sales, marketing, training,… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …market that are making a real impact on patient outcomes. Job Summary: The Associate Director of Post-Marketing is responsible for providing management of a ... Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Soleno (Redwood City, CA)
- …of bringing solutions to the PWS community. Summary of Job (brief description) The Associate Director / Director , Medical Affairs Strategy and Strategic ... provide specialist medical & scientific strategic and operational input into core medical affairs activities. Internally, the Associate Director / Director … more
- Organon (Plymouth Meeting, PA)
- …The Position The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory Chemistry, Manufacturing ... questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of… 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 ... patients the focus of every strategic decision. Role Summary As a member of the Public Affairs and Policy team, the Assistant Director of Public Affairs &… more
- Invivyd (New Haven, CT)
- …part of making a difference. Be part of Invivyd. Job Title: Senior Manager/ Associate Director , Drug Safety and Pharmacovigilance Operations Position summary: The ... Sr. Manager/ Associate , Drug Safety and Pharmacovigilance Operations encompasses a key...and Safety Data Exchange Agreements. Work cross functionally with Regulatory Affairs and Quality Assurance functions to… more
- BioSpace (Indianapolis, IN)
- …better for people around the world. Eli Lilly and Company seeks an Associate Director - Global Environmental Sustainability (P4) to provide functional ownership ... internally and externally to ensure that current and emerging global regulatory requirements, stakeholder expectations, and best practices are integrated into… more
- Urban Resource Institute (New York, NY)
- …with Associate Vice President of Justice Initiatives and Senior Director of Clinical Services, monitor equity metrics for staff and client satisfaction ... in the sector across the US and beyond. POSITION OVERVIEW The Clinical Director provides strategic leadership to Urban Resource Institute's clinical staff and across… more
