- Sumitomo Pharma (Albany, NY)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Regulatory Advertising & Promotion** . The Director is ... in the US. He/she will primarily function as the Regulatory reviewer for assigned products. This position is responsible...Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA. + Serve as internal… more
- Mizuho Corporate Bank (New York, NY)
- Summary The Liquidity Regulatory Reporting is a team responsible for the daily and monthly reporting and submission of FR2052A report for multiple entities under ... will be responsible for leading and managing the Liquidity Regulatory Reporting Mizuho Americas LLC production team, ensuring the...We participate in the E-Verify program. We maintain a drug -free workplace and reserve the right to require pre-… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …and execution of first-in-human, proof of concept (PoC), mass balance and drug interaction studies. The Director will author/review **clinical pharmacology** ... pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages **.** + Lead **clinical… more
- Pfizer (New York, NY)
- **JOB SUMMARY** The Director will plan, direct, and coordinate specialized and complex global development projects led by the Rheumatology group within the ... result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Develop and maintain project plans to closely track CDx development and CDx regulatory activities against clinical drug development and study timelines + Review ... Regeneron Pharmaceuticals has an exciting new opportunity as an Associate Director , Diagnostics Project Management & Delivery **In this role, a typical day might… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- As a Director in Pharmacometrics (Quantitative Pharmacology), this individual is is accountable for the delivery of support for one or more research & development ... programs, within their pharmacometrics discipline. In this capacity the Director is accountable for the timely and accurate delivery of needed quantitative analyses,… more
- Sumitomo Pharma (Albany, NY)
- …highly motivated, and experienced individual for the position of Executive Director , Commercial Manufacturing. This role is responsible for setting and executing ... the successful delivery of SMPA's commercial portfolio of products. The Executive Director will lead the RSM/API department, by alignment with business objectives… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director of Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. **In this role, a typical ... efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame… more
- Regeneron Pharmaceuticals (Armonk, NY)
- We are seeking a Director to join our Precision Medicine team. The Director , Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely ... with Senior Director , Precision Medicine CDx and key cross-functional collaborators to...both externally and internally + Have relevant knowledge of regulatory requirements (including IVDR) and support regulatory … more