Global Regulatory Affairs Manager
- Experience Level
- Senior Management
Exciting opportunity for a Global Regulatory Affairs Manager to join a established and expanding pharmaceutical business
I have partnered with a global pharmaceutical business who are looking for a Global Regulatory Affairs Manager to join there established and growing team. This business specialises in a variety of therapy areas and have over 200 products in there portfolio.
Prepare Regulatory submissions and conduct dossier due diligence along with identifying time lines for all new products.
Provide support and guidance to the Team when evaluating new projects.
Preparation and submission of regulatory applications for new pipeline products, including in-licensing, product developments and registering existing products into new markets.
Communicate with regulatory authorities on all new product submissions and other relevant issues.
Timely and accurate responses to all regulatory queries in relation to Regulatory Affairs-New Products.
Alliance Management of the relationship with all new partners and their regulatory departments to ensure timely feedback to all queries.
Discuss with senior management and project team progress and any issues for new products.
- Extensive Regulatory affairs experience.
- Dealt with customers globally.
- Past experience of working with new products.
- Experience working cross functionally with a number of different departments.
Competitive Package + More