Job Purpose

The Head, Regulatory Platform Excellence is an active and collaborative contributor to the Global Regulatory Platforms and Systems Leadership Team and is accountable for ensuring appropriate technical liaison and oversight of regulatory systems strategy/innovation, access, and systems specific business continuity globally for regulatory systems serving the broader R&D organization.

Key Responsibilities

• Develop and provide strategic direction for governance, compliance, access, and business performance as related to regulatory systems.
• Oversee and develop staff in the areas of Regulatory Systems Innovation, Integrated Systems Support and Data Architecture.
• Drives consistency and compliance across the use and development of innovative regulatory systems ensuring engagement and collaboration with the technical organization.
• Advise GRA and senior management on issues relating to regulatory systems, including adjacent systems as applicable.
• Interface with senior leaders across the businesses to develop, implement, and maintain policies and standards related to regulatory systems.
• Analyze changes to key Regulatory Health Authorities’ policies, as applicable, relating to regulatory systems and recommend/coordinate modifications of current practices when appropriate.
• Be responsible for business representation for all internal and external regulatory inspections or audits that involve regulatory systems.
• Define compliance and performance metrics to ensure regulatory systems are meeting and exceeding standards.
• Act as approver for documentation and systems that impact compliance with relevant regulatory requirements or regulations as applicable.
• Defines and sets objectives for the function to ensure continued alignment and pursuit of common goals.
• Drives a continuous improvement ethos and promotes a culture across the function to ensure compliance obligations are met.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Accountable to the Vice President, Global Regulatory Platforms & Systems, Global Regulatory Affairs for the direction, leadership and management regulatory system and related processes across the lifecycle.
• Undertake/oversee Business System Owner responsibilities on behalf of GRA including business continuity planning for regulatory systems.
• Develop robust regulatory systems strategy and identify opportunities for innovation/optimization.
• Ensure the proper maintenance of Written Standards relating to regulatory systems.
• Ensure appropriate & optimal user support and training is available.
• Provide technical liaison and oversight for other projects impacted by/benefiting from regulatory systems.
• Drive a culture of compliance, putting the patient first and ensuring transparency across the function encompassing a right first-time ethos.
• Coordinate and direct risk and mitigation plans for the function, ensuring timely and appropriate response and cohesiveness of approach.
• Driving a single vision and direction for the group, setting appropriate objectives and timelines for their delivery.
• Leverage internal and external networks to influence systems vendors/strategic partners and hold them accountable for their commitments to their development roadmaps.
• Global leadership including managing budget and resource within the Regulatory Excellence remit.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree.
• 10+ years Pharmaceutical industry experience with drug development and regulatory requirements.
• 10+ years Line leadership experience.
• Experience in Veeva Vault
• Experience with scientific data interpretation and labelling content.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master’s degree or higher
• Extensive knowledge of drug development and manufacturing and supply processes.
• Ability to effectively influence key stakeholders at all levels of the organization
• Consulting/advisory experience at senior management level
• The ability to influence effectively in a matrix.
• Highly developed interpersonal, presentation and communication skills with established internal and external networks.

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Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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