Vice President, Global Regulatory Affairs Strategy - RI&I

Position Summary

In this critical leadership role, the VP Global Regulatory Strategy RI&I will oversee regulatory strategy globally for the RI&I portfolio, including the associated communication strategy to all regulatory authorities. The VP will act as a direct link between Regulatory Affairs and all RI&I R&D stakeholders and provide the regulatory input to Governance decisions for clinical/project regulatory matters. They will also serve as a senior leader and the responsible head who ensures appropriate regulatory compliance in the conduct of global development programs and product lifecycle maintenance and license to operate activities for the RI&I portfolio.

This role will be a member of the Global Regulatory Strategy LT as well as leading the GRS RI&I team of approximately 60 FTEs.

• Directly accountable for global regulatory development and filings for the RI&I portfolio of products.
• Ensure that sound regulatory practices are fully integrated into pre-clinical, clinical and technical submissions, and that all documents submitted to regulatory agencies are reviewed to ascertain they are complete, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.
• Contribute to the creation and implementation of development plans that incorporate regulatory strategies designed to maximise the likelihood of successful regulatory applications, delivering regulatory approval, key labeling claims and reimbursement for all key indications.
• Exhibit leadership in the formulation and execution of global regulatory strategies and contribute to the development and implementation of policies and strategies for the optimisation of development, lifecycle maintenance and license to operate.
• Monitor and anticipate regulatory, scientific and pertinent legal issues and assess potential impact on GSK; advise senior management on events of significance to GSK’s business interests; proactively influence changes in guidelines and regulation to strengthen the regulatory review process and ensure core operations are proactively aligned with emerging policies.
• Develop and maintain excellent working relationships with FDA, EMA, PMDA and CFDA and other key international regulatory agencies, overseeing the planning and implementation of agency meetings as appropriate; assure collaborative approaches to product development and clinical plans with agencies via scientific advice and protocol assessment procedures.
• Provide leadership to assure appropriate regulatory compliance in the conduct and reporting of clinical trials, institutionalise policies and procedures and track performance.
• Attract, develop and retain key regulatory professionals, recognised for their strategic focus and regulatory and scientific acumen in alignment with the principles of Project First, Expert Led, and Tech Enabled.
• Represent Global Regulatory Affairs for RI&I on senior level decision making bodies.
• Act as a credible, influential, respected spokesperson during interactions with international regulatory agencies and external organisations, and ensure appropriate, proactive communication with agencies to assure expedient and efficient review and approval of submissions.
• Serve as an external proactive industry leader and influential spokesperson in support of GSK enterprise priorities and regulatory initiatives, and in shaping the external environment.
• Serve as the senior regulatory input to RI&I R&D stakeholders and senior level governance boards.
• Drive the GSK innovation culture including proactive individual and team adoption of the importance of digitalisation in development and regulatory decision making.

Basic Qualification - We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelors degree in Pharmacology, Immunology, Biology
• Experience leading the development of regulatory strategy within development programs;
  Experience working in early phase and late phase development projects as well as lifecycle
• People management and project leadership skills
• Regulatory affairs/product development experience of…