Senior Director Global Regulatory Strategy, Neurology in Hertfordshire

  • Salary: Competitive
  • REF Number: 00045495
  • Consultant: Mary Bolt
  • Contact: 01438 768717
  • Date Published: 13.05.2019
  • Sector: Neurology
  • Location: Home Counties
  • Discipline: Regulatory Affairs

Mary Bolt at CK Clinical is recruiting for a Senior Director Global Regulatory Strategy - Neurology to join a global pharmaceutical company in the Home Counties on a permanent basis.

The Company:

Our client is a global Pharmaceutical company who place patients and their families at the forefront of everything they do.

The Location: They are commutable from many towns in Greater London and from Middlesex to Cambridgeshire. There are good road and public transport networks including the M1 and M25 and London is easily reachable.

The Role:

The main purpose of the role will be to:

  • Monitor the EMA regulatory environment and assess implications for projects, define regulatory strategies, lead the execution of key business objectives or projects within the department and be nvolved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect.
  • Provide oversight for global regulatory strategies across portfolio and regions and direct initiatives to craft new policies that impact Global Regulatory Strategy.
  • Direct all regulatory planning and strategic activities for global regulatory submissions in target countries/regions and develop life cycle management strategies by fostering cross-functional collaboration to balance short- and long-term objectives.

Further responsibilities will include:

  • Contributing to and ensuring execution against strategy for interactions and negotiations with regulatory authorities.
  • Making appropriate budgetary allocations to targeted opportunities, managing contractors and ensuring that contractors, consultants and vendors complete assigned work according to agreed timelines and reviewing 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves discrepancies.
  • Managing individual contributors and people managers both locally and remotely and managing all employee-related activities throughout the year, including performance management and development.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or above in life science or a related field with extensive experience of working at a Senior level within Regulatory Affairs including regulatory strategy and processes and successful filing of MAA (or regional equivalent) in a major market/region.
  • Demonstrated strong EU regulatory experience and previous experience of line management.
  • Excellent communication and relationship building skills as well as being comfortable in leading and managing teams and working with external stakeholders.

For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email mbolt@ckclinical.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45495 in all correspondence.

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