over 1 year ago
My client is a market leader in the biopharmaceutical space that passionately develop therapeutic products to serve the significant unmet medical needs for rare diseases. The Director of Regulatory Global Labeling is a strategic and operational role that will manage labeling projects from start to finish.
The Director's responsibilities include:
- Providing regulatory strategic guidance and oversight of global labeling activities for development products and commercial products.
- Providing regulatory strategic guidance to development teams on the clinical design requirements to support labeling claims.
- Leading the Product Labeling Teams to develop labeling content for global and local labeling worldwide, including the development and management of the Company Core Data Sheets (CCDS) that ensure commercial product labeling is compliant with the worldwide regulations and is of the highest quality.
- Organizing and leading cross functional expert labeling Product Labeling Teams (PLT) (including experts from Regulatory, Clinical, Safety, Technical Operations, Supply Chain, Pharm Tox, REG CMC, etc.) to discuss labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CCDS, and assist with the preparation of high quality documents to support the creation of the CCDS and/or changes to the local labeling for assigned development projects or marketed products.
- Representing Regulatory Affairs as a member of product core teams to present strategic global labeling issues to Regulatory Management on an ad-hoc/issue-driven basis for assigned projects/products.
- Providing strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices.
- Preparing and managing international labeling, including tracking differences in local labels to the CCDS, ensuring local requirements are met, and translations are properly executed.
- Providing RA input to Periodic Safety Update Report (PSUR) and Annual Reports for assigned products.
The Director must have:
- BS or MS degree with requisite experience and demonstrated capability. An advanced degree (MD, Ph D, PharmD) is preferred.
- Required 8 to 10 years of regulatory pharmaceutical industry experience and extensive experience (at least 3 years) in global labeling, or equivalent experience.
- Outstanding interpersonal and communication (written and verbal) skills.
- Great attention to detail and excellent organization skills.
- A thorough understanding of regulatory labeling requirements and strategic labeling planning.
- Prior experience leading cross functional teams.
- Proven history of solving regulatory labeling related problems exhibiting superior judgment and a balanced, realistic understanding of issues.
- Fluency in English as business language.
- US regulatory experience required; EU experience is a plus.
- Ability to travel up to 20% of the time domestically and internationally.