Regulatory Affairs Manager
- Added on:
- 19 Jun 2019
- Contract type:
- Permanent
- Reference:
- 12442
- Location:
- Hertfordshire
- Base Salary:
- 80000
Description
Established, Successful, 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 £80K 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