Regulatory Affairs Manager

Highly Successful, Niche Pharmaceutical Company, Located Near St Albans, Hertfordshire, is Seeking a Regulatory Affairs Manager to Join their Dynamic Team of Professionals

Operating in a Highly Conducive Environment, this is a Senior Leadership Role where the Successful Candidate will ‘Make a Difference’

ROLE (Includes)

• Planning, Preparation and Submission of MA Applications in North America, Russia, and Australasia
• Addressing RFI/RTQ Response, Post Approval Variations (Administration, Quality, Clinical and Safety Changes), Renewals, Post Marketing Commitment Submissions
• Other Activities in Support of Maintaining MAs in the EU, MENA, Africa, Asia and UK
• Routine Liaison with CMOs and Third-Party Service Providers
• Direct Interface with 3^rd Party Service Providers, (Artwork, Labelling, Pharmacovigilance, Medical Information, Trademark, Publishing etc)
• Building and Maintaining Effective Relationships with Clients and Business Partners
• Gap Analysis of Regulatory Documentation, Identification of Potential Challenges and Solutions
• Developing and Maintaining Strong Working Knowledge of Regulatory Guidelines
• Remaining Current on Regulatory Changes, Including New Regulatory Agency Guidance and Revisions, Changes to Pharmacopeial Monographs and Implementation of New Requirements
• Assist in Clinical Trial Application Submission and Keeping Track of CT Progress

REQUIRED (Essential)

• Bachelor’s Degree or Higher Qualification in the Life Sciences
• Strong Knowledge of MHRA Regulations, GXP Requirements and ICH Guidelines
• Knowledge of EU DCP/National and Lifecycle Maintenance
• Authoring and Preparation of Regulatory Documentation Submission Packages
• Hands-On Experience of MA Transfers
• Reviewing/Annotating and Approving Artwork and Labelling
• Experience of Working with Regulatory Agencies for Clarification and Resolution

REQUIRED (Preferred)

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

REMUNERATION

• £60K Plus Benefits Package

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