Regulatory Affairs Officer - 6 Month Contract

Description

The role will ensure the individuals are motivated to contribute to the effectiveness of the overall team and departmental targets and objectives, and the wider business objectives.

Key Responsibilities:

Co-ordinate and / or prepare review, submit and subsequently manage applications to Regulatory Authorities in a timely manner. This will include:

variations and renewal requests for existing authorisations

answers to questions and post registration / approval submissions

clinical trial applications, ethical committee applications

meeting packages for scientific advice and protocol assistance

preparation of periodic safety update reports

prepare and update previously approved summaries of product characteristics

preparation and updating of previously approved product labelling texts and leaflets

• Manage and participate in cross-functional project teams covering:

Compliance with QMS and compliance of products to granted MAs

Conversion of MAA dossier to CTD format

Procedures and quality policy

Artwork / labelling

• Collect, review, organise, assemble and check reports and summaries
• Participate in departmental training programmes
• Work with and provide support to third party contractors for assigned projects
• Keep up to date with legislation and regulations and provide regulatory input to internal and external business partners
• Liaise with regulatory authorities and experts relating to regulatory submissions
• Provide information to the International and New Products Group as required.
• Responsible for providing information and data on regulatory and other activities to the Head of Regulatory Affairs
• Maintains good knowledge of relevant governance, SOP's and ways of working

Qualifications, skills & experience needed:

• Pharmacy, chemistry or life sciences graduate
• Membership of The Organisation of Professionals in Regulatory Affairs (or eligible to be a member)
• Articulate, methodical, attention to detail, flexible, team worker, energetic, self-motivated, down to earth, entrepreneurial.
• An achiever and good listener
• Minimum of 3 years Regulatory Affairs experience which includes the submission of variations, renewals new licence application submissions using as a minimum decentralised, mutual recognition and national procedures and preparation of PSURs.
• Experience in communicating and negotiating with the MHRA
• Experience in using Samarind Regulatory Management
• IT literate
• Understanding of e-ctd
• Able to work with and manage computer databases.