Regulatory Affairs Executive

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ReferenceLM/JT
Job TitleRegulatory Affairs Executive
Job TypePermanent
Job ScopeRegulatory Affairs & Regulatory Compliance
Business AreaOTC
LocationEast Kilbride near Glasgow, UK but could be flexible
SalaryExcellent
Websitewww.mentholatum.co.uk
Apply Online
Description

The UK division of The Mentholatum Company Ltd is part of the global Mentholatum / Rohto Pharmaceuticals group, though operates as an independent and self-governing business. It is a manufacturer of many leading international brands, including Deep Heat and Deep Freeze. The business investment in Research and Development is creating innovation in both existing categories and launching into new categories.

Duties and Responsibilities include but are not restricted to:

• Compilation of administrative and scientific documentation for international registration, including Export Certificates, in accordance with the respective defined formats, guidelines, and dispatch to relevant Agents/Distributors for submission to competent authorities.
• Maintain compliance of the Company’s product, Manufacturer’s and Wholesale dealers licences, submitting any changes to the authorities in a timely manner
• Compilation and maintenance of documentation necessary to ensure regulatory compliance of cosmetics, general products and medical devices.
• Contribute to regulatory strategy and tactics for obtaining clinical trials and marketing approvals, by participating fully in New Product Development project teams, and other relevant meetings
• Assess UK, Irish and European advertising and promotional materials for compliance with the appropriate marketing authorisation, the regulations, guidelines and the principles of any codes of practice.
• Draft and obtain internal agreement for texts such as but not limited to Summary of Product Characteristics, package labeling, consumer leaflet texts and the equivalent non-medicinal documents such as Instructions for Use and Technical Files for Medical Devices.
• Prepare, or review, expert reports for quality, safety and efficacy of Mentholatum products.

Requirements and Experience:

• Degree or equivalent preferably in life sciences or chemistry
• Experience in pharmaceutical regulatory affairs and in particular OTC medicines would be an advantage.
• Knowledge and application of the borderline between Medicines, Medical Device and Cosmetics
• Experience in interacting with third parties particularly in the Middle East would be an advantage
• Knowledge and application of UK advertising and promotional materials clearance
• Attention to detail and good written and verbal communication skills are essential.

Interested in a company with ambition, looking to the future then come and join us in East Kilbride. For the right candidate we could be open to some flexibility. Excellent opportunity for personal development within the company. To apply send your CV with current salary details to Julie Tannahill, HR Officer at tannahill@mentholatum.co.uk

Deadline: 2nd April 2017

Agency
OrganisationThe Mentholatum Company Ltd
Phone
Fax
Emailtannahill@mentholatum.co.uk
Address