to establish regulatory strategy for developing content for draft package inserts for NDA submissions. Interfaces with various... potential products for acquisition/in-licensing/joint development opportunities. Facilitates the regulatory strategy and serves...
requirements. This position reports to the Senior Director, Regulatory Strategy and will be based in Watertown, MA, with the..., but are not limited to, the following: Individual responsibilities Assists the Senior Director, Regulatory Strategy in implementing...
-rare disease patients who are in need of life saving treatments Job Description The Director Regulatory Advertising... and Promotion N.A is responsible for providing strategic and tactical regulatory ad promo support and guidance related to product...
Job Description We are seeking a dynamic and strategic Associate Director, Regulatory Affairs to join our Regulatory... Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies...
Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program... at our Waltham, MA office. This role is not eligible for fully remote work. Key Responsibilities: Lead regulatory CMC strategy...
and is onsite three days a week. You will report to the Director of Clinical Assay. Position Description Summary... understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a broad...
strategy -Solid experience in applications of advanced statistical methodologies -Leading roles in regulatory submissions...Job Description The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution...
candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director... programs he/she manages. The Associate Director in NSE has a broad understanding of toxicology and regulatory requirements...
commercializes IBSRELA in Canada. Position Summary: The Director, Cyber Security Operations is the senior leader responsible...'s business objectives, regulatory requirements, and evolving threat landscape while continuously improving the organization...
Director, Corporate and External Affairs, R&D Portfolio will lead corporate and external affairs strategy for CSL's pipeline...Job Description Associate Director, Corporate & External Affairs, R&D Portfolio Position Purpose: The Associate...
The Sr Director, R&;D Operations &; Innovation provides enterprise leadership across Product Development..., Packaging, Process, and External Innovation to translate Welch’s growth strategy into scalable, technically...
We are seeking a highly motivated and independent Associate Director with experience in hematology-oncology... Principal Scientist/Associate Director, In Vivo Pharmacology, you will be leading research to evaluate the efficacy...
The Business Development Director will play a central role in shaping and executing Sōlaria Biō’s commercial growth... strategy. Reporting directly to the COO, this individual will identify, structure, negotiate, and close strategic partnerships...
and Accountabilities The Associate Director plays an integral role leading a small team in the development of translational assays... Translational Medicine Department’s strategy. This includes clinical trial support, pre-clinical drug development, and cross...
The Director of Culinary Innovation & Menu Systems leads the enterprise-wide menu strategy, culinary R&D pipeline... therapeutic nutrition and regulatory requirements, and partnering cross-functionally with supply chain, procurement, dietetics...
Project Toxicologist, Director – Oncology Targeted Delivery (OTD) Safety Science, Clinical Pharmacology and Safety... individual to join us as a Director, Project Toxicologist, OTD Safety to contribute to the development of novel targeted oncology...
Job Description Role Summary: The Director, Clinical Operations is responsible for ensuring that clinical stage... superior execution, collaboration, and transparency across functions. The Director partners with internal stakeholders...
industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint... and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing...
industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint... and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing...
Job Category: Corporate Functions Degree Level: Bachelor's Degree Job Description: Position: Senior Director, New..., regulatory, research, commercial, CMC) to optimize the market value of asset Lead commercialization readiness efforts for late...