- Merck & Co. (North Wales, PA)
- …Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, ... Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- Larimar Therapeutics (Philadelphia, PA)
- …consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to ... day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global… more
- Eisai, Inc (Philadelphia, PA)
- …and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This ... and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the...equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of ... AAV, lentiviral, gene editing, cell-based therapeutics), a strong understanding of regulatory requirements, and the ability to work cross-functionally in a… more
- Merck & Co. (North Wales, PA)
- …will partner cross-functionally with global and ex-U.S. commercial, medical, access, policy , and compliance stakeholders to ensure that Therapy Patient Programs ... adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The Director will collaborate closely with the US patient… more
- Merck & Co. (North Wales, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable access to our medicines.The Senior… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Eisai, Inc (Exton, PA)
- …CAPAs.Help in the administration of external stability programs, ensuring regulatory compliance, adherence to protocol requirements and timely completion of ... and maintain SOPs, forms, protocols and other controlled documents.Draft regulatory documents to support IND/IMPD/BLA/MAA filings.Present assay/stability study results… more
- Merck & Co. (North Wales, PA)
- …support of pharmaceutical products Deep knowledge of our company's commercial, regulatory , and legal compliance policies Experience in the company end-to-end ... Health Economic Modeling, Health Economics, Health Economics Research, Health Policy Analysis, Health Technology Assessment (HTA), Interpersonal Relationships, Leadership,… more
- Bell Socialization Services Inc. (York, PA)
- …accurately and in a timely manner j) Utilize the On Call system according to policy (ex. calling off sick) k) Request permission from the DSPS to make changes in ... site b) Ensure all medical appointments are completed within regulatory time frames and that all paperwork is filled...The Direct Support Professional must be familiar with Bell's Policy and Procedures Manual, as well as philosophical beliefs.… more
