Regulatory Affairs Assistant

A top 10 biopharmaceutical company is seeking a Regulatory Affairs Assistant to join their team in Nottingham, UK on a contract basis.

Job Responsibilities:

• Provide full support to the Regulatory Project Leader to ensure that all aspects of the registration programme are conducted in accordance with the requirements of the company and the regulators.
• Provide support to the US for FDA submissions.
• Facilitate the product registration activities in Europe by compiling appropriate dossiers, submissions and responses to regulatory bodies.
• Maintain processes for submissions, interim notifications and periodic re-submissions.
• Maintain information on regulatory requirements and the status of product registrations.
• Liaise with product development groups, marketing and sales to co-ordinate timely approvals.
• Provide support and advice to worldwide company colleagues, particularly product development, marketing and sales, concerning international regulatory requirements in Europe.
• Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process.
• Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process.
• Provide information and support as appropriate to world-wide company colleagues

Education, Skills and Experience:

• Degree or equivalent preferred
• Forward planning, organisational and time management skills
• Ability to use own initiative, speedily and efficiently handle enquiries and requests
• Work to tight deadlines and remain calm in stressful situations
• Good knowledge of MS Office products, such as Excel, Outlook and Word essential

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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