Senior Regulatory Affairs Officer-Pharma-GMP-Berks-£30k-£40k-Authoring-Compiling-Dossier-GMP-MHRA
A market leading pharmaceutical business with a newly refurbished head office is currently undergoing a stage of expansion and as a result is seeking a Senior Regulatory Affairs Officer to join the business on a permanent basis. You will have prior regulatory affairs experience gained in another pharmaceutical company.
*Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
*Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
*Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
*Maintain up-to-date records and documentation in relation to Marketing Authorisations.
*Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
*Support other regulatory staff members within the Company when necessary.
*Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.
*Significant Regulatory Affairs experience within a pharmaceutical organisation
*Experience in authoring dossiers is essential
*Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
*Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
*Experience with Generic products and MRP/DCP submissions is advantageous.
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Posted: 12th January 2018
- Expires: 9th February 2018
- Reference: BBBH475911