- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, … more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …a Gilead company is hiring a ** Senior Medical Manager** to support US Medical Affairs . As a Senior Medical Manager, you have both field-based ... trends and competition. **Position Overview:** The Senior Medical Manager, Medical Affairs , will...all regulatory requirements and internal policies for medical affairs activities. + Support regulatory… more
- Abbott (Santa Clara, CA)
- …Our location in Santa Clara, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** ... member is responsible for the management and leadership of Regulatory Affairs activities for an early stage...to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory … more
- Edwards Lifesciences (Irvine, CA)
- …as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of ... the largest global medical technology companies in the world and is advancing...bd.com **How you'll make an impact:** + Represent the regulatory function on manufacturing and product development teams to… more
- AbbVie (Florham Park, NJ)
- … medical and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (Payers, ... is responsible for executing medical activities for multiple myeloma. + Medical affairs team lead for individual contributors responsible for the development… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more