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Job description

Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organisation provides regulatory leadership to CMC development teams and Global Manufacturing and Supply to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types and markets for marketed small molecules.

Ast the Regulatory Project Manager, you will be responsible for CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets.

This is an excellent opportunity for you to use and develop your CMC technical skills and regulatory knowledge for all regulatory active countries. We are keen to find someone who is committed to his personal development as this role will allow a fantastic career growth. If you are ready to take on a new challenge, make sure to apply for the role before the closing date to be in the running.

Watch Susannah Clements's video talking about this fantastic opportunity:

Key responsibilities:
• Lead the CMC Regulatory Matrix team for your assigned products and actively contribute to the broader Regulatory Product matrix.

• Partner with the manufacturing organisation to provide strategic regulatory advice in for change controls, develop regulatory strategies and plans through to implementation and lead authoring of the variation dossiers and responses to Regulatory Agency questions

• May be required to support product quality incident and product shortages

• Contribute to the review and implementation of new regulatory guidances

• Opportunity to become a technical or a country Subject Matter Expert

• May also take accountability for larger projects as part of a broader project plan i.e. line extensions, global strategic projects, system changes etc.

• Sets and resets priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives.

• Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines.

• Responsible for highlighting own training and development needs and working with his/ her manager to develop a training plan and achieve training goals.

We have announced recently that we are relocating all employees from Stockley Park to our headquarters, GSK House in Brentford, in Q2 and Q3 2020. We want to co-locate our teams and provide a modern fit-for-purpose working environment supporting GSK's Modern Employer ambition. While this role will be based initially at Stockley Park, it will move to GSK House in 2020.

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.

Closing date for applications: COB - 26th of June 2019

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.

*LI-GSK

Why You?Basic qualifications:
• BSc in Pharmacy, Chemistry or related scientific discipline or equivalent qualification
• Knowledge of drug development and/or manufacturing and supply processes
• CMC authoring experience
• Knowledge of CMC regulatory requirements
• Successful track record of managing multiple projects/teams simultaneously
• Excellent team working abilities and effective influencing skills
• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
• Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives

Preferred qualifications:
• Experience of evaluation and provision of CMC regulatory advice to in-licensing and divestment projects
• Participation in/leading business critical activities within and external to the organisation
• Demonstrated ability to train junior staff and the ability to motivate and lead others
• Ability to formulate complex regulatory submission strategies
• Successfully influenced and negotiated issues with regulatory agencies

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.

Learn more about GlaxoSmithKline

Be unique. Be authentic. However you prefer to say it, we really mean it. Our culture embraces people’s diverse perspectives and creates a positive environment where everyone belongs. We’re determined to build a better, more connected world for everyone.

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