An excellent opportunity has arisen for a Regulatory Affairs Officer to join a Hertfordshire based client within their exciting and fast moving team. The ideal person will have a strong background in EU regulatory and with a minimum of 18 months of industry regulatory exposure.
*Ensure suitable dossiers (new submissions, variations, and response to questions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission from third parties and provide advice regarding any deficiencies or issues
*Ensure databases and systems (including MyPortfolio and TrackWise) are updated in-line with current SOPs and up-to-date information for all assigned products
*Liaise with third parties to establish effective communication and relationships in order to progress regulatory activities
*Active involvement in due diligence activities including dossier audits, evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs
*Prepare regulatory strategies (including advising of the regulatory requirements) for new products and post-approval submissions with support from the Principal Registration Officer.
*Degree in relevant science e.g: chemistry, pharmacy, biochemistry, biomedical sciences etc.
*12 months regulatory affairs experience (ideally within the EU)
*The ability to work under pressure, manage multiple projects and meet tight timelines.
*IT skills (Proficient in Microsoft Office, Adobe etc)
*Proficiency in speaking, comprehending, reading and writing English is required
Why this role?
My client are able to offer excellent career progression, and the chance to join a global health care company that is making a difference and changing lives. An excellent salary and benefits package is on offer with this role.
For further details about this role or other vacancies within Regulatory Affairs please contact Tim Barratt on +44(0)1727 817 626 or send a copy of your CV to firstname.lastname@example.org
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