Senior Regulatory Officer
- Experience Level
- Experienced (non-manager)
A fantastic vacancy has become available for a Senior Regulatory Officer in Slough. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.
- Ensure that submissions of marketing authorisations, variations, renewals, periodic safety update reports and relevant clinical trial applications are made to the regulatory authorities in a timely and professional manner.
- Ensure updates to product information (SmPCs, PILs, Labels, Packaging) are updated in line with licence maintenance activities, and that briefings are sent to appropriate audiences, both internal and external, in a timely manner
- Work with global regulatory colleagues in the preparation and submission of responses to regulatory authority questions
- Manage safety updates to marketing authorisations, including management of risk management plan updates
- Prepare, submit and follow up applications for export certificates to the MHRA and/or HPRA
- Cooperation with other departments (medical affairs, marketing, etc.) for the purpose of obtaining / receiving / expanding and maintaining the approvals.
- Ensure business stakeholders are informed of all relevant regulatory updates
- Assist the market access team with Pharmascan activities, by providing regulatory timelines on request
- Participate in the review of product prescribing information in line with the ABPI Code for the UK and IPHA Code of Practice for Ireland
Skills and Requirements
- Life sciences or chemistry graduate to honours level or equivalent Master's Degree, Post Graduate Diploma or PhD preferred Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs) Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.