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Position Purpose

The European Regulatory Procedural Strategist (ERPS) team leads and manages the procedural and operational aspects of the European regulatory filings within the European Centralised Procedure, working in close collaboration with the European Regulatory Liaison group and the appropriate regional and global functions.

Key Responsibilities

·       Manages the operational and procedural aspects and provide support for new Marketing Authorisation Applications’ preparation and filings and also Life Cycle Management for the European Centralised Procedures

·       Plan and track activities related to regulatory submissions in the EU.

·       Systematic communicator of regulatory submission dates, regulatory status, nature of changes, track and inform of minor/significant product information changes to all relevant parties.

·       Provide logistic support for meetings with EMA and national Health Authorities and any other related meetings in connection to the assigned project.

·       Working together with the European Regulatory Liaison (ERL) in the development process of European strategy through research (competitors, guidelines...) and membership of multidisciplinary Project Teams (including with business)

·       Author regulatory documentation in Module 1, and lead review of quality variations.

·       Back-up ERL as needed, in teams and with Health Authorities.

·       Lead reviews of new legislations and guidelines as appropriate, and author/review internal procedures and processes. Represent the group in inter-departmental (global) taskforces.

·       Develop and ensure maintenance planning, tracking/monitoring of processes.

·       Keep abreast of regulatory requirements and changes, competitive activities, changes in Governmental authorities and requirements to enhance the effectiveness of the function.

Qualifications and Experience

·       Solid scientific background (PhD level desired).

·       Demonstrated (hands on) experience of direct (or relevant) in European regulatory procedures or (in)direct management experience of major projects

leadership skills.

Key competencies

·       Work on LCM and MAA with minimum supervision, support early projects, take leadership role for non-project based support. Take initiative to support and serve as backup for other ERPS

·       Represent the department in Global task forces, develop processes inter and intra dept.

·       Take part of the training and integration of new members.

·       Great communication, organisation and attention-to-detail skills as well as in depth knowledge of EU Regulatory requirements are clear specificities and a “must” for the job.

·       Good interpersonal skills, strong team spirit and ability to “connect and collaborate” are found essential for this particular job due to the high team collaboration and practice harmonisation expected from this group as well as to the extent of the cross-functional interactions involved in the daily work.

·       Excellent command of spoken and written English.

·       Ability to rapidly adapt to different issues and projects at one time.

·       Good understanding of the pharmaceutical industry and have an understanding of European Regulatory Procedures.