- Brandeis University (Waltham, MA)
- …best practices in online learning. About the Position and Course Course Title: Regulatory Science & Quality Control This course provides an in-depth examination ... an industry leader to teach in our Master of Science in Applied Biotechnology & Enterprise program. Brandeis University...of regulatory frameworks governing biotechnology products, including FDA, EMA, and… more
- Merck & Co. (Rahway, NJ)
- …leadership and functional capability to keep pace with the changing science and regulatory environment.Establishing and effective implementation and oversight ... precedent setting.- Guides internal teams to implement rigorous, innovative, and science -based approaches to regulatory interactions and requirements.- Uses… more
- Merck & Co. (North Wales, PA)
- …Life Science , Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, Science {+ 4 ... specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (North Wales, PA)
- …Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science , Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... Management.Education Min. Requirement: BS/BA or an equivalent certification/experience in science , engineering, IT or related discipline with functional working… more
- Merck & Co. (South San Francisco, CA)
- …the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused on bringing AI/ML approaches to bear to improve the speed ... enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role in developing,… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Merck & Co. (Millsboro, DE)
- …Operations, Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance, Safety Practices, Science , Standard Operating ... Procedure (SOP) Writing, Sterilizing Equipment, Test and Evaluation (T&E) {+ 3 more}-Preferred Skills:Job Posting End Date:07/31/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a high-performing organization that:Attracts and cultivates essential skills needed for data science and AI, ensuring the team remains at the forefront of industry ... but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in ... Role OverviewAs part of the US Medical Affairs team, the Senior Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (North Wales, PA)
- …Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data Science , Numerical Analysis, Physiology, Regulatory Compliance, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Insmed Incorporated (San Diego, CA)
- …industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment ... thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's...(CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- BioSpace (Tarrytown, NY)
- …D, Ph.D., MD or DO) preferred in the field of medicine or science . Regulatory experience can offset education requirements. Advance knowledge of regulations, ... Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with… more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... 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 leading… more
