Senior Director, Global Regulatory Strategy

£0.00 - £110000 per annum
  1. Permanent
  2. Senior/Director & VP
  3. United Kingdom
Hertfordshire
Posting date: 15 May 2019
RA.RE.23356_1557927817

A leading pharmaceutical client is searching for an Senior Director, Global Regulatory Strategy to join their team in Hertfordshire. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

The Senior Director will monitor the EMA regulatory environment, assess implications for Eisai projects, and define regulatory strategies. They will be responsible for training and mentoring Neurosciences GRS staff in the UK and act as the Administrative Head for Neurosciences UK GRS staff and budget.

Job Responsibilities:

  • Leads execution of key business objectives or projects within the department.
  • Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect.
  • Leads execution of key business objectives or projects within the department
  • Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect
  • Directs all regulatory planning and strategic activities for global regulatory submissions in target countries/regions.
  • Defines regulatory support strategies and mobilizes the required resources to deliver optimal support to project teams through regulatory sub teams.
  • Develops life cycle management strategies by fostering cross-functional collaboration to balance short- and long-term objectives.
  • Contributes to, and ensures, execution against strategy for interactions and negotiations with regulatory authorities.
  • Integrates and implements new resources (tools, systems, vendors, etc.) and techniques with existing ones.
  • Sets overall deadlines for projects within the function and tracks project milestones.
  • Manages contractors and ensures that contractors, consultants and vendors complete assigned work according to agreed timelines.
  • Makes appropriate budgetary allocations to targeted opportunities.
  • Reviews and escalates changes in program/ department budget.
  • Directs the use of financial standards across work teams for consistent level of compliance.
  • Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves discrepancies.

Skills and Requirements:

  • BS/MS in relevant field
  • Extensive experience in regulatory strategy and processes in industry setting required, including successful filing of MAA (or regional equivalent) in a major market/region
  • Demonstrated strong EU regulatory experience
  • Prior successful MAA submission experience essential
  • Prior people management experience essential
  • Previous neurosciences experience desirable
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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