The Group Head of European Regulatory Maintenance is responsible for leading and managing the European Regulatory Maintenance function for all registered and/or marketed products (some 260) across all Business Units and Business Franchises within this leading company.
Duties:
Lead the creation of regulatory strategies for all EU license renewals and EU Type II variations (except CMC-related variations) for products registered via the: Centralized procedure (CP), Mutual Recognition Procedure/Decentralized Procedure (MRP/DCP), National Procedure (Renewals only).
Create, build-up and lead cross functional teams as needed. Support EU referrals to ensure a smooth progression of the procedure by providing the BF/BU manager with source documentswhere needed to achieve the best possible labelling harmonization across EU.
Interact with Health Authorities to solve regulatory issues.
Represent in Industry Interest groups and external working groups (e.g. EFPIA, DIA), where appropriate.
Provide training to members of other line functions, CPOs or representatives of other DRA groups, Regulatory Maintenance practices and on relevant regulatory requirements or guidelines related to maintenance of in-market products.
Participate in multidisciplinary teams for continuous improvement of internal procedures and management objectives when appropriate.
Ensure that the team organizes and leads the execution of EU PL readability testing, negotiate with and supervise external consultants and contractors.
Qualifications:
PhD or equivalent scientific degree.
Fluency in English as a business language, other European languages of advantage
Advanced knowledge and experience of European regulations, guidelines and regulatory processes for in-market products
Several 6 years of relevant experience in Drug Regulatory Affairs.
Strong leadership skills and at least experience in leading positions (in-market areas).
Ability to have a leading role in a DRA specific or^cross functional ad hoc special project.
Extensive European knowledge/experience in the main areas related to development and life cycle management of products within the pharmaceutical industry.
Proven ability to manage and develop people and to work in multicultural / multidisciplinary teams (global and local).
Excellent interpersonal, communication and negotiation skills, and proven ability to work effectively in a matrix environment