At a Glance
- Tasks: Oversee UK regulatory compliance for pharmaceutical products and improve quality systems.
- Company: Dynamic global pharmaceutical company focused on innovation and compliance.
- Benefits: Flexible working, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career development.
- Why this job: Make a real impact in healthcare by ensuring product safety and compliance.
- Qualifications: 3-5 years in regulatory affairs with a degree in pharmacy or life sciences.
The predicted salary is between 35000 - 45000 £ per year.
I am partnering with a Mid size Global Pharmaceutical client who are currently recruiting for a Regulatory Affairs Executive who will be responsible for 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.
The ideal person will have the following skills, experience and personal attributes and have around 3-5 years 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 compliance with local regulatory requirements and corporate requirements.
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.
Your main responsibilities will involve:
- 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:
- 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.
Regulatory Affairs Specialist employer: Parkside Recruitment
Parkside Recruitment is an excellent employer that values its employees by fostering a supportive and dynamic work culture in Ruislip. With opportunities for professional growth and development, the company encourages a proactive approach to work, ensuring that every team member feels valued and empowered. The unique blend of a fast-paced environment and a focus on employee well-being makes it a rewarding place to build your career.
