Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the... development and implementation of global regulatory strategies for all assigned products and therapeutic areas, with the intention...
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...
Reporting to the Head of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading... meetings, core submission meetings and other cross functions meetings. Provide global regulatory Affairs-CMC strategic...
of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities... and other cross functions meetings. Provide global regulatory Affairs-CMC strategic guidance to project teams and ensure timely...
, Director (Global Regulatory Lead (GRL)), in the development and execution of the regulatory strategy. Assigned matters may... contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal...
Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion... to the VP, Global Regulatory Affairs, Advertising and Promotion, this role also provides direction for collaborative systems...
into the Director, Global Regulatory Affairs. Responsibilities and Duties Act as the Global Regulatory Lead on multi... Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based...
Job title: Director, US Regulatory Affairs - Advertising and Promotion Location: Cambridge, MA or Morristown, NJ.... In at least one product area, you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion (A&P...
Director of US Regulatory Affairs and Quality Management at Servier Pharmaceuticals, reporting to the Senior Director... function, and ensuring timely submissions are made to OPDP. The Director will proactively review regulatory guidelines...
Provides program leadership and develops CMC regulatory strategy in support of global vaccine programs in various stages... of development Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data...
with Global Regulatory Leads and escalate issues when necessary, proposing risk mitigation strategies. Requirements: 10..., analyze competitor labeling and trends, and develop competitive labeling strategies. Ensure alignment with global regulatory...
Job Description General Summary: The Regulatory Labeling Associate Director will be responsible for strategic... (IFUs). Contributes to labeling strategy with a proficient ability to advise stakeholders of regulatory labeling...
Job Description General Summary: The Regulatory Strategy Director will be responsible for the development... of broad regulatory ideas/tactics supporting program strategy. This roles assignments may be global, regional or local...
Job Description General Summary: The Regulatory Strategy Director will be responsible for the development... to post marketing application stage) outlined in Global Regulatory Strategy Documents supporting the Pain portfolio products...
regulatory strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead..., Director, in PDT R&D: Serves as the global regulatory lead for one or more projects and and includes leadership of the Global...
of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director... tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed...
regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff... strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally...
of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead... Associate Director, you will be responsible for complex or highly complex or multiple projects. May lead the Global Regulatory...
Job Description General Summary: The Senior Director, Regulatory Labeling is regulatory labeling leader with expert... regarding labeling requirements globally, including development and life-cycle management of TLPs, CCDS and of global regulatory...
: 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...