Location: Guildford, Surrey
Closing Date: 10 Dec 16
Salary (£): On Application
• Office based Surrey • Full time • Permanent position • Healthcare company
The source department of Chiltern acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Regulatory Affairs Executive, for our client, a specialist transdermal technology company with scientifically advanced products in development in the fields of analgesics/anti-inflammatories and erectile dysfunction. The position is permanent with my client and would be full time and office based in Guildford.
This role involves contributing to the regulatory strategies to meet global requirements, writing regulatory documents, and liaising with regulatory bodies, as appropriate. R&D including the Regulatory function in the company is small and entrepreneurial and operates virtually with high quality contractors and consultants. The role reports to the Head of R&D.
• Engage with consultants to define regulatory strategies for the R&D programs
• Define and agree data requirements for global programs in close collaboration with the clinical development and product development functions. Ensure overall regulatory timings are met and data quality is acceptable
• Prepare regulatory briefing documents and submission dossiers in accordance with global requirements
• Engage with regulatory authorities as appropriate
• Communicate regulatory positions in internal meetings
A full job description is available
• Minimum 5 years industry experience in OTC/Rx Regulatory Affairs with proven track record of dossier approval
• Experience in EU and/or FDA regulatory frameworks and requirements. Knowledge of other key territories would be a bonus.
• Experience in Class III medical devices (with ancillary medicinal substances) preferred
• Degree in pharmacy, life sciences or related discipline
• Knowledge of Medical Device/OTC/Rx Drug Development process
• Ability to understand complex scientific programs and translate into high quality regulatory documentation
• Ability to work across many boundaries in a collaborative manner. Commercial, Clinical Development, Product Development, Licensing Partners
To apply for this position or for more information about the role please contact Julia Thomson, Julia.firstname.lastname@example.org, +441753216725.
Please note that if your experience does not mirror that of the requirements for this role you may not receive a response.
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
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