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Regulatory Affairs Manager

Added on:
16 Jan 2019
Contract type:
Permanent
Reference:
12442
Location:
Hertfordshire
Base Salary:
70000

Description

Exceptional Career Opportunity in a Senior Regulatory Affairs Role with the Chance to make a Significant Contribution to a Well Established and Highly Successful, Niche Pharmaceutical Company, Working within a Highly Conducive Environment, Located on the London/Hertfordshire Boarder

ROLE - Includes

  • Planning, Preparation & Submission of MA Applications, Post Approval, Variations, Renewals, Post Marketing Commitment Submissions & Other Activities in Support of Maintaining MAs in the EU, MENA, Africa, Asia & the UK
  • Working with Colleagues to Determine the Viability of Entering New Markets & the Regulatory Requirements, Timelines & Conditions
  • Reviewing and Submitting Artwork & Labelling Changes, Including Management of Third-Party Artwork Houses
  • Managing External Pharmacovigilance & Medical Information
  • Building and Maintaining Effective Relationships with External Clients/Partners & Contemporaries
  • Managing/Supporting a Range of Changing Project Demands
  • Gap Analysis of Regulatory Documentation, Identification of Potential Challenges & Proposal of Solutions
  • Developing & Maintaining Strong Working Knowledge of Regulatory Guidelines
  • Liaising with Regulatory Authorities for Advice, Guidance & the Resolution of Issues that Might Arise
  • Ensuring All Relevant Electronic Systems are Updated & Maintained in Alignment with Regulatory Submissions and Commitments
  • Ensuring All Processes Conform to Guidelines & Standard Operating Procedures (SOPs)

REQUIRED - Essential

  • Bachelor’s Degree Equivalent or Higher Life Science Qualification
  • Strong Knowledge of MHRA Regulations
  • Knowledge of DCP/National and Lifecycle Maintenance
  • Authoring & Preparation of Regulatory Packages & Documents for Submissions
  • Direct, Hands-On Experience of MA Transfers
  • Reviewing/Annotating & Approving Artworks & Labelling
  • Experience Working with Regulatory Agencies to Clarify & Resolve Regulatory Matters

REQUIRED - Preferred

  • Change Control, Corrective and Preventive Actions (CAPA) & Deviation Procedures
  • Knowledge of EU, Asia and MENA Regulations and Post Approval Procedures
  • Conducting Gap Analysis & Review of Dossiers
  • Implementing Falsified Medicines Directive
  • Creating and Authoring SOPs
  • Consolidation of Dossiers into eCTD