At a Glance
- Tasks: Oversee UK regulatory compliance for pharmaceutical products and improve quality systems.
- Company: Join a dynamic mid-sized global pharmaceutical company with a collaborative culture.
- Benefits: Flexible working, competitive salary, and opportunities for professional growth.
- Other info: Work in a supportive environment that encourages innovation and continuous improvement.
- Why this job: Make a real impact in healthcare by ensuring product compliance and improving processes.
- Qualifications: 3-5 years in regulatory affairs with a degree in pharmacy or life sciences.
The predicted salary is between 51750 - 63250 £ 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 is in line with the MHRA and European Guidance on any regulatory activities for all relevant products.
1 day per week in their offices
The ideal person with 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 the compliance to local regulatory requirements, and corporate requirements
- 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
- 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
- Ensures 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 (Sm PC) and Patient Information Leaflets (PIL)
- Attend internal and external meetings as required, to influence and drive the regulatory requirements
Regulatory Affairs Specialist in London 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.
