Parkside Recruitment
Regulatory Affairs Specialist
London
Posted 1 day ago
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About the Role
I am partnering with a mid-size Global Pharmaceutical client who are currently recruiting for a Regulatory Affairs Executive.
Responsibilities:
- UK specific regulatory oversight on marketed products
- Improving QRVI systems and processes
- Reviewing documents and managing the Affiliate in line with the MHRA and European Guidance on any regulatory activities for all relevant products
Work Arrangement:
- 1 day per week in their offices
Ideal Candidate:
- Around 3-5 years of experience
- Competence in:
- Regulatory variations for MHRA
- Understanding of variations for EMA
- Experience of working in a matrix environment
- Self-starter, not afraid of change, speaking up, wants to improve processes
- Detailed approach to work
- Team player
- Ensure that prevailing legislation, GCP, Ethical Committee, and SOP and local requirements, and the appropriate Codes of Practice requirements are fulfilled
- Contribute proactively to a credible image for the affiliate in the local Health Care and Medical community
- Organise internal audits for the affiliate, to evaluate the compliance to local regulatory requirements, and corporate requirements
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Corporate image and Compliance
Special Competencies / Other Requirements:
- Degree in pharmacy, life science or a recognised healthcare professional degree / qualification
- Good knowledge of Regulatory legislation where appropriate
- Practical experience in interacting with and influencing the MHRA
- Experience in process mapping and writing process documents and driving continuous improvement
- Flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, facilitates and drives change where appropriate
- Challenges and questions ways of working to seek improved processes
- Excellent attention to detail
Main Responsibilities:
- Striving to constantly improve the QRVI systems and processes
- Representing the RA function within Regulatory meetings, giving advice to maintain/improve quality performance
- Ensuring that the Affiliate is in line with the MHRA and European Guidance on any regulatory activities for all relevant products
- Reviewing documents that directly affect RA activities
Key Accountabilities:
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- Responsible for UK specific regulatory oversight on marketed products:
- Prepare and deliver regulatory operational plans for assigned projects/products
- Advising on local strategy and procedures
- Serving as the primary regulatory liaison between:
- MHRA and OPUK
- OPUK and the wider business
- Preparation and submission of variations to the MHRA
- Working with the Regulatory Publishing Group as required
- Updating of Module 1 (Module 1 of the CTD) in order to assist in the preparation of dossiers for MA application
- Ensure maintenance of regulatory databases and trackers
- Provide regulatory input on artwork and product information
- Regulatory compliance – write, review, develop, validate, and maintain local regulatory SOPs in line with local regulatory legislation, guidelines, issues, practices, and corporate procedures
- Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL)
- Attend internal and external meetings as required, to influence and drive the regulatory requirements
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Skills
Regulatory Affairs
MHRA Variations
EMA Variations
Process Mapping
Regulatory Compliance
GCP
SOP Development
CTD Module 1
SmPC Management
PIL Management
Internal Auditing
Stakeholder Management
Quality Performance
Regulatory Oversight
Dossier Preparation
Project Management
Location