Regulatory Affairs Assistant in Leeds

14 Jan 2019
11 Feb 2019
Regulatory Affairs
Contract Type
Jenni Woolley is recruiting for a Regulatory Affairs Assistant to join a company in the Pharmaceutical industry at their site based in Leeds on a 12 month contract basis.
The Company:
Our client is a multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company who offer the worlds most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.
The Location:
The Regulatory Affairs Assistant will be based in Leeds. Leeds is the largest city in the county of West Yorkshire and is known for its shopping, nightlife, universities, and sports.
The Role:
The Regulatory Affairs Assistant will carry out the following duties:
• 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.
Your Background:
To be considered for the role, you should have the following skills, knowledge 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. 

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43839 in all correspondence.

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