Regulatory Affairs Manager

Medical Technology

Surrey

Permanent ⁄ £60000 - £65000

Updated May 5, 2012

Based at the company's head offices in Surrey, the Regulatory Affairs Manager will play a critical role in delivering regulatory affairs project activities for one of the products.

Your key responsibilities will be to;

• Prepare and deliver regulatory submissions (CTAs, INDs,MAAs, NDAs, annual reports, variations, renewals, Response to questions) in line with defined CMC Regulatory plans.
• To advise corporate project teams on regulatory requirements and registration strategy.
• To collate and review relevant data for submission to regulatory authorities in accordance with local requirements.
• Participate on multi-disciplinary project teams and provide comprehensive input in determining the regulatory pathway.
• Maintain documented regulatory project plans in line with best practice recommendations within CMC and the Regulatory Affairs department.
• Prepare and maintain CMC regulatory submissions involving the collection, review, and assembly of scientific, medical, manufacturing, and other supporting documentation.
• Update Functional leads and maintain transparency of information across Regulatory function.

Who we're looking for
To be considered for this role you will need to display competencies in the following areas.

• Experience in pharmaceutical regulatory affairs is essential.
• Candidates must have good solid CMC experience with pharmaceutical products.
• Knowledge of FDA regulatory procedures a must. Good knowledge of European regulatory procedures would be advantageous.
• Must have strong organisational and written/verbal communication skills, attention to detail, commitment to quality, demonstrated problem-solving abilities, editing and computer skills.
• Must be self-motivated with ability to effectively manage/prioritise multiple tasks.
• Experience with drug/device combination products desirable

About our client
Our client is a major Medical Technology business based in Surrey. The business has an interesting portfolio of products is a subsidiary of a major pharmaceutical business. The Regulatory Affairs Manager will be an integral part of the regulatory management team.

What's on offer
£45,000 - £55,000 plus benefits

Michael Page Contact
For further info, apply or phone on 0113 388 9000. Job Ref: 13217176
Your application will be sent to Richard Goodall.

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