Title: Director of Regulatory Labelling
Summary:
A global Biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Director of Regulatory Labelling to join their team! The team is growing rapidly as they have had great commercial success and multiple products in their pipeline. They are looking for someone who is very dedicated and has proven success in the Regulatory Labelling field in the US and EU. This role is based on their Pennsylvania location and would give you an amazing opportunity to contribute to the company's mission to improve patient's lives.
The Director will be responsible for...
- Providing regulatory expertise to drug development teams, as well as controlling the consistency of labelling throughout process
- Provide Regulatory labelling expertise and guidance to cross functional teams to align with US and EU requirements
- Managing FDA-required SPL documents
- Coordinating EU SmPC updates and managing translations, linguistic reviews, and readability for EU products
- Coordinate US labelling submissions, approval, and implementation activities internally and externally
The Director should have the following qualifications:
- BS in life sciences or related field, advanced degrees are strongly preferred
- 10+ years of branded Regulatory Labelling experience for pharmaceutical products
- Strong global understanding of labelling requirements
- Strong communication and teamwork skills
