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...
worldwide. Could you be our next Executive or Senior Director Search & Evaluation Late TA Lead, (Im CV or He)? The.... Position Description Summary The Executive Director of Search & Evaluation will lead strategic sourcing and evaluation...
difference worldwide. Could you be our next Director, Search & Evaluation Early TA Lead? The job is in our Waltham MA Office... 1 assets, building a robust pipeline of opportunities aligned with TA strategy. Co-lead internal meetings (with Late...
that make a meaningful difference worldwide. Three Director of Search & Evaluation to lead strategic sourcing and evaluation... assets, building a robust pipeline of opportunities aligned with TA strategy. Co-lead internal meetings (with Late Search...
Repligen is seeking a hands-on, strategic Sr. Director, Global IT Infrastructure & Operations to lead the design... strategy, while overseeing internal teams, MSPs, and vendors to ensure high-quality, secure, and reliable services...
Officer, the Director, Human Resources Business Partner (HRBP) provides HR leadership and consultation to client groups... within multiple functions, including Discovery & Development, Clinical & Medical Affairs, Program Management and Regulatory. The HRBP...
patients who are in need of life saving treatments Job Description The Director of Project Management will provide... objectives and regulatory requirements. This position will also be responsible for driving additional projects in line with the...
patients who are in need of life saving treatments Job Description The Director of Project Management will provide... objectives and regulatory requirements. This position will also be responsible for driving additional projects in line with the...
Director, Commercial Reporting. In this pivotal role, you will drive the development and enhancement of Ardelyx's commercial... biopharmaceutical environment. Reporting to the Executive Director, Business Analytics, you will play a critical role in analyzing...
Role Overview & Key Functions:: The Associate Director, Document Management and Trial Master File (TMF) provides... execution. The Associate Director serves as a subject matter expert for TMF processes and contributes to the continuous...
worldwide. Could you be our next Senior Director Search & Evaluation Late TA Lead, (He)? The job is in our Waltham MA Office... therapeutic strategy and integrating late-stage external innovation priorities into portfolio planning. Lead proactive sourcing...
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...