Our client is in search of candidates who demonstrate a keen interest and enthusiasm for tackling the intricate regulatory and policy challenges within the Medicaid program. This includes assisting with transaction structuring and negotiation, providing strategic counsel on regulatory and compliance...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. ...
Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lex...
Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL. Moderna The...
As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates acceptable skills with increasing independence ...
The Associate Director, Regulatory Affairs CMC is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs. Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory asse...
Join Takeda as an Associate Director, Global Regulatory Lead, GI & Inflammation where you will define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates acceptable skills with inc...
Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned p...
The Associate Director, Regulatory Advertising & Promotion will be tasked with leading, initiating, reviewing and approving strategies for non-promotional and promotional materials to comply with regulatory requirements worldwide throughout the product life cycle. Will coordinate regulatory training...
Responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development supporting the Company's preclinical/clinical development/commercial programs, including, developing regulatory strategy for all phases of drug development in order to progress reg...
Our client is in search of candidates who demonstrate a keen interest and enthusiasm for tackling the intricate regulatory and policy challenges within the Medicaid program. This includes assisting with transaction structuring and negotiation, providing strategic counsel on regulatory and compliance...
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. Associate Director, ...
The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. This goal must be achieved both as a component of an overall glo...
SummaryA career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices. You’ll help build too...
Sr Associate, Regulatory Affairs Sr Associate, Regulatory Affairs sought by Karyopharm Therapeutics, Inc. Newton, MA: Manage reg submissions, publish and prep submission docs, proficiency with eCTD tools and processes, track regulatory filings, etc. ...
Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexingt...
Healthcare and Life Sciences Regulatory Associate (Corporate). Our client, a top Am Law 100 firm, is seeking an experienced healthcare regulatory associate to join its Healthcare and Life Sciences Practice. Minimum of 3 years of healthcare regulatory experience in (i) reimbursement (including both r...
Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on stra...
Role that serves as a Health Authority liaison and key member of project teams, establishes and communicates regulatory strategies for development programs and coordinates the timelines, generation, and submission of complex regulatory dossiers. Maintains knowledge of regulatory requirements and ant...
Collaborates with other functional work teams , Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projec...
Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on stra...
The Associate Director of Regulatory Affairs Strategy will be responsible for developing regulatory strategies to support clinical development plans, working cross-functionally across the organization. Associate Director, Regulatory Strategy. Associate Director of Regulatory Strategy. Ensure adheren...
Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexingt...
Assists in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions. Job Description PURPOSE AND SCOPE: Assists in the support of the daily ope...