- Amgen (New Albany, OH)
- …a Packaging facility. Responsibility includes maintaining production in full cGMP compliance . Supervises, hires, and develops staff and ensures production schedules ... shift. **Specific responsibilities include but are not limited to:** Compliance : + Evaluate and approve reports and protocols. +...Assure all corporate change control procedures are followed, and Regulatory and QA are made aware prior to the… more
- KPH Healthcare Services, Inc. (La Crosse, WI)
- …concerns and issues that affect resident care, medical care, quality of life, and/or regulatory compliance + Spend an appropriate amount of time on each ... needs and provides a tailored program that encompasses the educational, regulatory and cost-containment concerns of the facility while assuring appropriate… more
- Sumitomo Pharma (Augusta, ME)
- …and aggregate safety reports + Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight ... EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep knowledge of chemical/ pharmaceutical ...+ Strong understanding and experience in Data Integrity and Compliance + Experience preparing and/ or leading regulatory… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and ... collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review INDs, NDAs, and other … more
- Charles River Laboratories (Rockville, MD)
- …as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of ... execute training and Management briefings at any technical or compliance level required on updates and regulatory ...+ Minimum 8 years of experience in a biologics, pharmaceutical , medical device, or related industry. 10 years of… more
- Sumitomo Pharma (Indianapolis, IN)
- …with brand strategy and market access goals. + Collaborate closely with **legal, compliance , privacy and regulatory teams** to ensure program design and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Charles River Laboratories (Rockville, MD)
- …as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of ... stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations,… more
- Sumitomo Pharma (Pierre, SD)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO… more
- W. R. Grace (Columbia, MD)
- …Ability to assess supplier capabilities including technical transfer, scale-up, and regulatory compliance . + Excellent negotiation and contract management ... and CDMO services. This role ensures optimal supplier selection, cost efficiency, and compliance with global regulatory standards. The ideal candidate will have… more