Regulatory Affairs Executive - Slough, United Kingdom - Parkside Office Professional

Parkside Office Professional

Verified Company

Slough, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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, reviewingdocuments and managing the Affiliate is in line with the MHRA and European Guidance on any regulatory activities for all relevant products.

HYBRID WORKING WITH 1 DAY IN THE OFFICE

Excellent benefits

The ideal person with have the following skills, experience and personal attributes
- 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
Preparation and submission of variations to the MHRA
Working with the Regulatory Publishing Group as required
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

Parkside Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.