Regulatory Affairs Manager

Biotechnology

Manchester

Permanent ⁄ £35000 - £45000

Updated May 5, 2012

As Regulatory Affairs Manager you will manage the development, implementation, and maintenance of Regulatory strategies, submissions, and activities.

You will be required to;

• Interpret and apply regulations by creating regulatory strategies for domestic and international markets.
• Define, monitor, collate, and publish deliverables for submissions.
• Lead regulatory submission teams.
• Write and/or edit submission documents using regulatory templates, or create new templates.
• Review validation, clinical, and stability protocols for regulatory soundness.
• Participate on product development core teams as regulatory representative.
• Review and approve advertising and promotional materials for regulatory compliance.
• Ensure health hazard assessments are performed for regulatory reporting of product problems.
• Prepare and review regulatory agency information packages and submissions.
• Interact with regulatory agencies.
• Participate in Material Review Board and complaint/recall meetings.
• Assess and approve labelling, process, and procedures changes for regulatory impact and ensure maintenance of regulatory compliance.
• Provide recommendations on labelling, manufacturing, analytical, and clinical study plans for regulatory compliance.
• Advise and guide management and other personnel in other departments on the interpretation and application of regulations.
• Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives. Assess impact and disseminate throughout the organization for continued regulatory compliance.
• Develop staff skills, abilities, and experiences for succession.
• Perform other related duties as assigned.

Who we're looking for
This is an excellent opportunity to join a growing business within the In-Vitro Diagnostics sector. To be considered for this role you will need to display the following criteria of abilities;
•Several years experience in the in vitro diagnostics, medical device or pharmaceutical industries within a breath of Regulatory roles.
• You must have advanced knowledge of applicable regulations and standards.
•To independently plan, execute, and/or problem solve moderate to complex situations.
• To exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Must demonstrate initiative, balanced assertiveness working as a team player.
• Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
• Ability to manage multiple projects

About our client
Our client is a an established Biotechnology business based in the Manchester area. The Regulatory Affairs Manager is a newly created role following the relocation of the business to Manchester

What's on offer
£35,000 - £40,000 plus an excellent benefits package.

Michael Page Contact
For further info, apply or phone on 0113 388 9000. Job Ref: 13217218
Your application will be sent to Richard Goodall.

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Please note, any salary/salary range and benefits described in this advertisement, are indicative only. The actual salary offered to the successful candidate may vary and will be dependent on skills and experience.

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