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Regulatory Manager

We are looking for a Regulatory Manager to join our quality team here at GSK Worthing.

The QA Regulatory Manager is responsible for maintaining current regulatory documentation for all Worthing site processes responding to changing business and regulatory agency requirements. In this role you will provide expert regulatory knowledge to the site to ensure continued licence compliance and successful implementation of projects.

Your Key Responsibilities focus on:

• Lead the maintenance of site compliance to licences/ pharmacopoeias and worldwide regulatory requirements.
• Manage the preparation and review of submissions for variations/supplements for all Worthing site products.
• Liaise with Global Post Approval Regulatory Affairs to review questions from global regulators and provide and agree official responses.
• Provide expert regulatory advice critical to the development and implementation of strategic projects and for ongoing production batch destination.
• Approve Technical Terms of Supply and Technical Agreements with global markets and 3rd parties.
• Lead the setting and registration of appropriate specifications for all site products.
• Provide regulatory support for Level 3 and 4 audits.
• Management of the site regulatory team and budget.

Interested in join the team?

Please note this role will be based at our site in Worthing West Sussex. At Worthing, our focus is to manufacture and supply the broad-spectrum antibiotic, Augmentin as oral tablets, suspensions and sterile injectable dose forms. Worthing Site is a mixed manufacturing site with complex regulatory pressures. Manufacturing processes are highly technical and include high hazard activities.

Closing date for applications: COB - Friday 8th March 2019

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Thank you for your interest in this opportunity.


Why You?Basic qualifications:
The successful candidate should have a degree in a scientific or engineering discipline. In addition you will also have:

• Comprehensive knowledge of worldwide regulatory requirements and current standards and formats
• Comprehensive knowledge of operations in areas of expertise, e.g. steriles, packaging, manufacturing,
• Understanding of mechanisms involved in Pharmacopoeial monographs/test methods and General Notices
• Awareness of the regulatory requirements of change and impact on business processes of delays
• Good knowledge & understanding of the QMS and change control system in particular.
• Computer Skills - Excel/PowerPoint/Word.

Preferred qualifications:
• MSc in a scientific or engineering discipline
• Strong listening skills, analytical ability to diagnose problems, planning and management skills and the ability to develop practical solutions.
• Excellent communication skills, both interpersonal and presentation; able to interact with and influence all levels of individuals across a variety of organizations (without a direct reporting relationship).

Why GSK?:
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

Contact information:
You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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