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Senior Regulatory Affairs Manager

This job is no longer available

Key People Pharmaceutical
Monday, July 30, 2012
Monday, August 27, 2012
Tim Barratt
South East England, England
Result Type
Position Type

Further information

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

Key People Pharmaceutical

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