Senior Regulatory Affairs Manager

South East England, England
Jul 30, 2012
Aug 27, 2012
Tim Barratt
Result Type
Position Type
Full Time

Overview: Within this role you will act as the EU Regulatory Lead who will be responsible for one or more products. The role will involve: leading regulatory aspects of a product's development, including strategic and project delivery; working with internal teams and providing subject matter expertise globally. Responsibilities: - Be the key EU regulatory contact for teams, LOCs and the regulatory authorities for a product/group of products - Provide EU regulatory input to the Global Regulatory Team (GRT) - Be responsible for the regional strategy and execution of the preparation of MA and life cycle submissions (post approval variations, responses to agency questions) - Be responsible for the regional strategy and as applicable execution of the regulatory aspects of the clinical trial program in the international region. - Assemble and provide timely regional regulatory input to Global Development Team (GDT) and other cross-functional project meetings consistent with GRT strategy. - Develop proactive relationship with these regulatory authorities. - Provide technical and/or managerial support for the creation review and finalisation of components of CTA and/or Marketing Applications as well as routine regulatory submissions - Review and approve promotional and non-promotional materials for use in international region. Background Experience: - Relevant Bachelor's degree is essential - In depth practical experience of the drug development process, from early phase to approval, as well as post-marketing experience - Experience of managing a centralised procedure for regulatory submissions including post-marketing activities - Direct experience of contacts, meetings, presentations etc with EU regulatory authorities, including the EMA - Scientific expertise and acumen to work with colleagues across disciplines leading the regulatory agency submission process - Experience gained within a biologics organisation - Second degree or further education/qualifications - Project management Expertise - Oncology experience