- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, ... Associate Director will be responsible to: + Develop regulatory strategy for their assigned products, in order to...marketed products throughout the entire life cycle of the drug . + Represent Global Regulatory Affairs within… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting ... coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the… more
- Organon & Co. (Plymouth Meeting, PA)
- …( Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule ... in accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...be critical in helping our teams accelerate progress. The Associate Director, Global Regulatory Affairs - Global… more
- Boehringer Ingelheim (St. Joseph, MO)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety and efficacy… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …& Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- GRAIL (Durham, NC)
- …partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director, Clinical Compliance will play a key leadership role in ... you'll collaborate cross-functionally to proactively manage both GCP and CDx regulatory risks, lead inspection readiness, and continuously improve quality standards… more
- Takeda Pharmaceuticals (Boston, MA)
- …meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small Molecules where you will...post-market support. + Proven ability to provide strategic regulatory guidance to drug development, registration, and… more
- Mizuho Corporate Bank (New York, NY)
- Regulatory Reporting Quality Assurance, Associate Quality Assurance Unit: The Quality Assurance Unit is responsible for enhancing the integrity of the bank ... regulatory reporting processes, reporting data quality as well as...We participate in the E-Verify program. We maintain a drug -free workplace and reserve the right to require pre-… more