Regulatory Affairs Executive - Pharmaceuticals

Reference:

659782

Sector:

Operations, Operations Manager

Salary:

£50,000 to £60,000 Per Annum

Town/City:

Slough

Contract Type:

Permanent

Date Posted:

15/11/2022 10:12:00

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.

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
  • 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

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