Regulatory Regional Hub Strategist

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United Kingdom
Kent, England
Posting date: 08 Sep 2020
31643

An exciting vacancy has opened for Regulatory Regional Hub Strategist in Kent. This is an excellent opportunity to work with one of the most prestigious pharmaceutical establishments in the world.

Job Responsibilities

  • Ensure uncompromised compliance and embrace corporate culture.
  • Understand local regulations and trends for assigned markets.
  • Manage initial and post approval submissions for assigned markets.
  • Enable initial and post approval strategy (including timelines) and execution in alignment and partnership with key to ensure a submission ready dossier.
  • Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.
  • Author local submission components as needed.
  • Liaise with the manufacturing sites for obtaining supporting documents as needed.
  • Communicate changes to regulatory requirements and update the appropriate system in a timely manner.
  • Work in collaboration across the regulatory organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
  • Contribute to local and regional regulatory initiatives promoting a culture aligned with the company values and which supports compliance and innovation

Skills and Requirements

  • Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science.
  • MSc, MBA or PhD may be an advantage.
  • Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
  • Technically competent to understand CMC submissions, interpret and communicate BoH requirements, and identify potential regulatory risks.
  • Knowledge of drug development practice, rules, regulations and guidelines.
  • Strategic and analytical thinking.


To Apply

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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