- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific and ... regulatory efforts of the team, overseeing CMC ...are documented. **Minimum Qualification Requirements:** + BS, MS, or PhD in Chemistry, Biology, Engineering, or closely related science… 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
- Lilly (Indianapolis, IN)
- …that make life better for people around the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join us in developing and ... need them all over the world. We are seeking Regulatory Scientist GRA CMC-Parenteral Commercial Products to be a...processes including response to questions. OR + Advanced degree ( PhD , MS) in a science, engineering or related field… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial… more
- Globus Medical, Inc. (Audubon, PA)
- …Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps ... abreast of regulatory procedures and changes. Recommends strategies for earliest possible...or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience + 5+… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …organizations ** Regulatory and Compliance:** + Ensure compliance with all regulatory requirements and internal policies for medical affairs activities. + ... a Gilead company is hiring a **Senior Medical Manager** to support US Medical Affairs . As a Senior Medical Manager, you have both field-based as well as office-based… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …possible** with us. Reporting directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs has the responsibility to support ... the VP, Medical Affairs in providing medical, scientific and technical customer-focused leadership and strategic perspectives across the Specimen Management (SM)… more
- AbbVie (San Francisco, CA)
- …on qualifications listed below. Purpose: The Scientific/Medical Director, Medical Affairs provides specialist medical and scientific strategic and operational input ... into core medical affairs activities such as: health-care professional and provider interactions;...content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for… more
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