Regulatory Affairs Associate

Highly Successful, Niche Pharmaceutical Company, Located Near St Albans, Hertfordshire, is Seeking a Regulatory Affairs Associate to Join their Dynamic Team of Professionals.  Operating in a Highly Conducive Environment, this is a Role where the Successful Candidate will ‘Make a Difference’

ROLE (Includes)

• Supporting the Regulatory Affairs Manager to Plan, Prepare and Submit MA Applications in Various Global Markets and Addressing RFI/RTQs Received from Regulatory Authorities
• Work in Conjunction with Regulatory Team Colleagues on Post Approval Variations, Renewals, Post Marketing Commitment Submissions and Other Ad Hoc Activities in Support of Maintaining MAs in the EU, MENA, Africa, Asia and UK
• Developing a Thorough and Up-to-Date Understanding of the Regulatory Environment and Supporting Data Requirements
• Reviewing and Submitting Artwork and Labelling Changes
• Direct Interface with 3^rd Party Service Providers, (Artwork, Labelling, Pharmacovigilance, Medical Information, Trademark, Publishing etc)
• Building and Maintaining Effective Relationships with Clients and Partners
• Gap Analysis of Regulatory Documentation, Identification of Potential Challenges and Solutions
• Developing and Maintaining a Strong Working Knowledge of Regulatory Guidelines
• Keeping Current with Regulatory Changes, Including New Regulatory Agency Guidance and Revisions

REQUIRED (Essential)

• Bachelor’s Degree or Higher Qualification in the Life Sciences
• Minimum 2-3 years’ Experience in a Regulatory Role
• Knowledge of Relevant Regulatory and MoH Guidelines is Preferable
• Knowledge and Experience of Product Lifecycle Maintenance
• Authoring and Preparation of Packages and Documents for Regulatory Submissions

REQUIRED (Preferred)

• Experience of Working with Regulatory Agencies for Clarification and Resolution

REMUNERATION

• £40K 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