Regulatory Affairs Officer
- Employer
- Barrington James
- Location
- Crawley, West Sussex (GB)
- Salary
- £28,000-£38,000
- Start date
- 23 Sep 2022
- Closing date
- 23 Oct 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
To maintain all UK Product licences in accordance with the UK regulatory guidelines (MHRA), ensure all UK licence applications are submitted in accordance with company expectations
Key Duties and Responsibilities
Please note; this list is not exhaustive and responsibilities may include any other reasonable requests in line with your skill set
- To ensure that the company’s products comply with the regulations of the Medicines and Healthcare Regulatory Agency (MHRA)
- To support the regulatory department with eCTD submissions by either National, DCP and MRP procedures.
- Assist and coordinate site transfer projects.
- To prepare submission of licence variations and renewals to strict deadlines,
- Partake in the interfacing with regulatory authorities to facilitate the approval of submissions
- Maintain up-to-date records and documentation in relation to Marketing Authorisations.
- Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.
- To comply with office policies and guidelines.
- Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners.
- Perform product information compliance activities for the entire product life cycle.
- Check, approve and release labelling/ packaging documents for contract manufacturing sites and own site.
- Work closely with in-house,3rd party designers and contract sites for packaging artwork development and updates.
- Work with outsourced Pharmacovigilance team for new MA applications, submissions related to Summary of Product Characteristics (SmPC), Patient Information Leaflets (PILs) and renewals.
- Support and maintain labelling systems, process and related activities as required.
- Identify any compliance issues or gaps and support Line Manager in evaluating business impact and corrective actions.
- To gather all required documentation for the administrative sections of CTD dossier.
- Work collaboratively across organization and contract sites.
- Perform other appropriate duties, where necessary.
Personnel Specifications
Knowledge & Experience
- Experience with communicating with the MHRA at an administrative and strategic level
- Understanding of European / UK regulatory guidelines, regulations and procedures
- Understanding of the timescales of the approval processes within the MHRA
- Understanding the company Regulatory Affairs SOP’s
- Understanding of pharmacovigilance practices and procedures
Personal Skills
- Ability to manage conflicting priorities
- Excellent communication skills
- Strong interpersonal skills
- Accurate
- Methodical
- Attention to detail
- Proactive
Our Values:
- Integrity
- Passion for Excellence
- Participative Decision Making
- Concern for Society & Environment
- Fairness for Care
- Transparency
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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