Director of US Regulatory Affairs and Quality Management at Servier Pharmaceuticals, reporting to the Senior Director... and operational goals are met in conjunction with Sr Director, Medical Operations Quality Management Responsibilities Write...
Sr. Manager/Associate Director, Regulatory Affairs Strategy – Labeling Who we are: is a biopharmaceutical company... Pharmaceuticals is searching for a Senior Manager/Associate Director of Regulatory Affairs Strategy - Labeling to join our growing...
development of innovative regulatory affairs and CMC regulatory strategies, guidance and play a critical role overseeing the... and leverages their extensive experience to represent regulatory affairs in discussions with external and internal stakeholders...
of development Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data..., directly and indirectly. ACCOUNTABILITIES Leads planning, execution, and management of regulatory submissions for assigned...
Job Title: Global Medical Affairs Senior Director Kevzara Grade: L4-2 Location: Cambridge, MA About the...: Effective stakeholder management, and role model for collaboration and teamwork Highest ethical, regulatory and scientific...
Job Description General Summary: The Medical Affairs Medical Director will provide medical leadership for the... Affairs organizations, GAPP and Corporate Communications, Legal, Compliance (OBIE), Regulatory, Research & Development, HRBP...
Job Title: Medical Affairs Director - Evidence Generation, Respiratory Location: Cambridge, MA Our Medical function... serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions...
Regulatory Affairs strategies and tactics, procedures and practices Oversees the development and management of project plans... pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the...
within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience...Job Description General Summary: The Senior Director, Regulatory Labeling is regulatory labeling leader with expert...
Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit.... This position will be responsible for auditing/reviewing regulatory submissions, working closely with the Regulatory Affairs...
: Regulatory Strategy, Labeling & CMC, Regulatory Policy, Regulatory Intelligence, Federal Government Affairs, Safety, and Quality... approval), regulatory strategy for new products and line extensions, Hatch Waxman issues and life cycle management, and design...
requirements. Serves as the primary liaison to the US FDA and provides support for regional and local regulatory affairs teams.... Creates high quality, complaint regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant...
The Director Country Operations Management (DCOM) will lead a local execution team, fully accountable for all study..., and management of site engagement, respectively. Contributes to high quality re/feasibility work, using data driven approach...
Program Management, reporting directly to the Senior Director Medical Operations, will partner with functional leads... will support the organization through project management, including contracting and vendor oversight for Medical Affairs...
and Data Management (IDM) Section. This position reports to the Division Director of the Technical and Financial Support...Who We Are: The Executive Office of Energy and Environmental Affairs (EEA) seeks to protect, preserve, and enhance...
with other groups e.g. Research Groups, Early Development, Regulatory Affairs, and commercial functions; Works as an internal expert... of brilliant and diverse minds to make a real difference, there's only one choice. Senior Director, Early Clinical Leader The...
and engagement. We serve as key strategic partners for commercial, regulatory, R&D, market access and external affairs to develop... with global regulatory environments and requirements Experience in lifecycle management and launch readiness activities...
, and Engineering (DTE), Legal, Regulatory Affairs, Patient Safety, Compliance Quality Systems, and the Office of Business, Integrity...Job Description General Summary: The Executive Director of Medical Information, Technology, and Innovation (MITI...
terms while ensuring compliance with quality standards and regulatory requirements. Risk Mitigation - Assess and mitigate... risks associated with suppliers, including supply chain disruptions, quality issues, and regulatory compliance. Develop...
Job Title: Director, HCP Marketing, Respiratory Location: Cambridge, MA About the Job We are seeking a dynamic... and experienced HCP Marketing lead for Dupixent Respiratory. The Director, HCP Marketing, Respiratory will focus on developing...