- Merck & Co. (Upper Gwynedd, PA)
- …CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance with global regulations… more
- Merck & Co. (Rahway, NJ)
- …Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... development of regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and 4+ ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design… more
- Olema Oncology (Boston, MA)
- …feel better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, ... Experience: 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within… more
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate … more
- Eisai, Inc (Nutley, NJ)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Accede Solutions, Inc. (Lexington, MA)
- Hybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This ... to the corporate goals. Coordinate responses to CMC-related inquiries from regulatory agencies with thorough submission management Support preparation for Health… more
- Merck & Co. (Rahway, NJ)
- …Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Merck & Co. (Rahway, NJ)
- …record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. Educational background ... West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - As an… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …5+ years or Master's/ Bachelor's with minimum 8+ years relevant experience in pharmaceutical regulatory affairs. Minimum of 5 years of experience (preferably ... are making a real impact on patient outcomes. Job Summary: The Associate Director of Post-Marketing is responsible for providing management of a post-marketing … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise in Lean ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations… more
- Merck & Co. (Rahway, NJ)
- …Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause ... Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that ... manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished...(API), biologics, vaccine drug substances and finished products. As Director , you will support Quality audits and health authority… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The ... Director / Senior Director , Procurement is responsible for...for multiple facets of the Procurement function within a pharmaceutical manufacturing environment including, but not limited to, purchasing,… more
- Merck & Co. (Rahway, NJ)
- …Immunochemistry, Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design, Product Development, Regulatory ... Job DescriptionDirector, Oral Formulation Sciences Job Description:Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules… more
- Genmab (NJ)
- …like 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 ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
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