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Regulatory Affairs Manager

Added on:
12 Mar 2019
Contract type:
Permanent
Reference:
12442
Location:
Hertfordshire
Base Salary:
75000

Description

Established, Successful, Pioneering Niche Pharmaceutical Company, is further Expanding their Regulatory Affairs Team and the Regulatory Affairs Manager will be a Key Member of the Leadership Team

A Significant Period in the Growth of the Company, a Highly Conducive Working Environment, a Dynamic Team of Colleagues, in a Business where Significant Contributions are Well Rewarded, makes this an Exciting Career Opportunity for the Right Candidate

ROLE

  • Planning, Preparation and Submission of MA Applications, Post Approval, Variations, Renewals, Post Marketing Commitment Submissions and Other Activities in Support of MAs in the EU, MENA, Africa, Asia and UK
  • Transfer of MA’s in Collaboration with Regulatory Colleagues
  • Determination of the Viability of Entering New Markets and the Regulatory Requirements, Timelines and Conditions in Collaboration with Commercial Colleagues
  • Reviewing and Submitting Artwork and Labelling Changes
  • Managing External Pharmacovigilance and Medical Information
  • Building and Maintaining Effective Relationships with External Clients/Partners
  • Managing/Supporting a Range of Changing Project Demands
  • Gap Analysis of Regulatory Documentation
  • Developing and Maintaining Strong Working Knowledge of Regulatory Guidelines
  • Liaising with Regulatory Authorities
  • Responsibility for Ensuring All Relevant Electronic Systems are Updated and Maintained

REQUIRED (Essential)

  • Bachelor’s Degree Equivalent or Higher Qualification within Life Sciences
  • Strong Knowledge of MHRA Regulations
  • Knowledge of DCP/National and Lifecycle Maintenance
  • Authoring and Preparation of Regulatory Packages and Documents for Submissions
  • Direct Experience of MA Transfers
  • Artwork and Labelling Review and Approval
  • Experience of Working with Regulatory Agencies
  • Proficiency in Excel and Word

REQUIRED (Preferred)

  • Experience of Change Control, CAPA and Deviation Procedures
  • Knowledge of EU, Asia and MENA Regulations and Post Approval Procedures
  • Conducting Gap Analysis and Review of Dossiers
  • Creating and Authoring SOPs
  • Consolidation of Dossiers into eCTD

REMUNERATION

  • Basic Salary of £75K Per Annum

RESPOND

  • Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV