Our client, are market leaders in the manufacture and supply of specialty pharmaceuticals and services for healthcare professionals in the UK and worldwide. They are seeking a Regulatory Affairs Officer for their location in Essex.
The Regulatory Affairs Officer prepares and submits regulatory submissions into designated health authorities within agreed timeframes, assisting in the preparation and submission of responses to requests for further information from Health Authorities and assists in the drafting and review of label and leaflets in support of the above submissions.
PRINCIPAL RESPONSIBILITIES include:
Ensuring that correct fees are paid to health authorities for any submissions where fees are payable
Ensuring that data requirements for required submissions are communicated and generated to deliver the change required within the required time
Ensuring regulatory approvals are communicated and ensuring changes are implemented
Liaise with regulatory authorities concerning submissions
Prepare and submit U.K and EU licence applications, variations and renewals within agreed timeframes using defined procedures
Assist in the preparation and submission of responses to requests for further information from Health Authorities to submissions made by the company.
Assist in the drafting and review of label and leaflets in support of the above applications
Assist in the preparation of periodic safety reviews
Provision of regulatory advice and guidance to colleagues in other departments
Collect, review, organise, assemble and check reports and summaries
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Degree in Pharmacy, Chemistry or Life Science
Previous experience in the Pharmaceutical industry would be beneficial
PERSONAL SKILLS & ATTRIBUTES:
Good communication and interpersonal skills
Good technical skills
Team working ability
Fforde is acting as a recruitment agency/business.
KEY WORDS: Regulatory Affairs, Drug Development, Drug Safety, Clinical Research, Clinical Trial, Clinical Study, Submission, Degree, Pharmacy, Chemistry, Life Science, Pharmaceutical, CRO, Essex, UK