Regulatory Affairs Separation – Marketing Authorization Workstream Lead

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Regulatory Affairs Separation – Marketing Authorization Workstream Lead

The key purpose of this role is to provide regulatory leadership, governance, and expertise to oversee and deliver the Marketing Authorization (MA) / Product Transfers / Name Change and regulatory impact of the Separation plans for the Consumer Health business.

In this role you will:

• Focus on delivering:

• MA/Products Transfer / Name Change plan aligned with supply chain and markets (on time and to budget).

• Factory name changes plans and regulatory execution.

• QP release change plans and regulatory execution.

• QPPV and PSMF change plans and regulatory execution.

• Build a network of collaborative relationships within the separation project (including SMO, Region and Market separation leads, supply chain, quality, legal), working with GSK at the enterprise level (aligning with Vx and Rx) for the shared brands and with the strategic external regulatory partner - PwC.

• Raise and mitigate regulatory issues as they arise.

• Work closely with GSK Vx and Rx to ensure consistent ways of working on required MA/product transfers.

Why you?

Qualifications & Skills:

• Degree in a pharmaceutical or life science or equivalent regulatory experience.

• Significant experience in regulatory affairs, and a proven record of developing regulatory strategies for complex projects and resolving issues.

• Proven and significant experience with at least two of; medicinal, cosmetic, medical device and food product regulations.

• Experience of working flexibly across different projects / products / areas, and awareness of regulatory processes in different geographic regions.

• Operational knowledge of MA transfer / Name Change on large scale (>1000)

Preferred Qualifications & Skills:

• Master’s degree or higher is preferred.

Application Details:

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please submit a cover letter with your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information provided in your cover letter and CV will be used to assess your application.

Closing date for applications: 23rd of January 2022

Thank you for your interest in this opportunity!

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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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