Regulatory Affairs Manager

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