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.  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 and Addressing RFI/RTQ Response, Post Approval Variations (Administration, Quality, Clinical and Safety Changes), Renewals, Post Marketing Commitment Submissions and Other Ad Hoc Activities in Support of Maintaining MAs in the EU, MENA, Africa, Asia and the UK, Involving Liaising with CMOs and Third-Party Service Providers
• Managing Current Site Transfer Project, Working with Various Departments and Liaison with CMO, Advising on Process Validation and Method Transfer etc
• Working Alongside Regulatory Colleagues to Transfer MAs Worldwide back to from Current MA Holder
• Managing External Pharmacovigilance, Medical Information 3rd Party Agent, Local Translators, Trademark Providers, Publishing and Consular Service Providers
• Building and Maintaining Effective Relationships with External Clients/Partners/Local Distributors, Alongside Partner’s Regulatory Teams
• Gap Analysis of Regulatory Documentation, Identification of Potential Challenges and Proposal of Solutions
• Develop and Maintaining Strong Working Knowledge of Regulatory Guidelines and Remain Current Knowledge of Regulatory Changes
• Liaising with Regulatory Authorities for Advice, Guidance and if Necessary, Resolve Issues
• Practical Knowledge of Submission Portals eg MHRA Portal and CESP etc
• Assist in Clinical Trial Application Submission and Keep Track of Clinical Trial Progress
• Perform Global Regulatory Assessment as Changes initiated and Plan Submissions
• Initiate, Review, Close and Implement QMS Related Activities eg Change Control, Deviations and CAPA etc
• Review of Prescribing Information as per ABPI/PMCPA code
• Review and Submissions of PSUR, RMP and CCDS
• Support for Annual Product Quality Review (APQR) for Relevant Product Responsibilities

REQUIRED (Essential)

• Bachelor’s Degree Equivalent or Higher Qualification within Life Sciences
• Strong Knowledge of MHRA Regulations
• Strong Knowledge of GXP Requirements
• Strong Knowledge of ICH Guidelines
• Knowledge of DCP/National and Lifecycle Maintenance
• Authoring and Preparation of Regulatory Packages and Documents for Submissions
• Direct, Hands-On Experience of MA Transfers
• Reviewing/Annotating and Approving Artworks and Labelling
• Experience with Managing a Site Transfer
• Experience Working with Regulatory Agencies to Clarify and Resolve Regulatory Matters
• Ability to Project Manage and Prioritise Workload

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 P/A with an Excellent Complimentary Package of Benefits

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