Globalisation Regulatory Manager

Basic qualifications:
• BSc or equivalent Pharmaceutical or Life Sciences.
• Strong scientific background, with the level of Regulatory experience to work efficiently with minimum guidance and supervision.
• Significant relevant experience in a related Regulatory Affairs role.
• Proven record of developing regulatory strategies for complex situations.
• Experience of working flexibly across a portfolio of products.
• Awareness of regulatory processes in different geographic regions.

Preferred qualifications:
As above.

Details:
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.

We are currently recruiting a Globalisation Regulatory Affairs Manager to be based in Weybridge, Surrey, UK.

The successful candidate will be involved with a diverse range of activities including:

• Comprehensive understanding of Global Regulatory requirements especially in the regions concerned (Asia, M East, Africa, Latina etc) with the ability to portray these accurately in Global Regulatory strategies and provide insights into the plans required to successfully deliver globalisation of innovation.
• Agree plans required for Regulatory submissions in markets to meet project timings, expectations and milestones.
• Proactively seek updates and changes in Regulatory Intelligence for market requirements and communicate these to relevant stakeholders.
• Manage the execution and delivery of 'Right First Time' dossiers, ensuring filings for planned initiatives are completed as planned.
• Expertise in using required IT Regulatory systems, including Cx OPAL and Documentum.
• Critical assessment of processes and systems, initiates improvements as required.
• Act as Regulatory expert in project teams, working with cross-functional teams and Category colleagues to provide strategy and solutions to overcome issues and challenges.
• Take ownership of Regulatory-specific processes; establish improved ways of working/communication within Central Regulatory, LOCs and manufacturing sites.

Closing date for applications: Monday 30th October 2017.

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 . This will help us to understand any modifications we may need to make to support you throughout our selection process.

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.

Thank you for your interest in this opportunity.

*LI-GSK

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

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