Senior Director, US Regulatory Policy

Job Purpose

The role is responsible for the leadership of a team focused on defining and driving the US regulatory policy, advocacy and intelligence activities to ensure optimal advancement and life cycle management of GSK’s biopharmaceutical portfolio.  Actively shape the evolving US regulatory environment and enable GSK to influence and respond to strategic regulatory changes in the external environment (including coordination and alignment globally) in a compelling, science driven manner. Utilize their extensive external and internal stakeholder network to enable GSK advocacy activities. 

Key Responsibilities

• Lead a team and direct the development and maintenance of the US regulatory policy, advocacy and intelligence strategies and priorities aligned to the global regulatory and GSK business priorities in support of the biopharmaceutical portfolio. 
• Provision of interpretation, advice and perspectives on possible impact on GSK of new legislation, guidelines and policies for the US.
• Lead the development and implementation of plans and actions to influence regulatory opinion leaders in the external environment, including global stakeholders where expertise is needed
• Influence the adoption of appropriate implementation activities within GSK ensuring active participation in specific GRA implementation teams to address major legislative changes as required
• Maintain links with key external stakeholders and networks including regulatory agencies, governments, trade associations
• Represent GSK and/or trade associations at key Agency and Industry meetings, e.g., PhRMA
• Member of the Regulatory Policy network and Regulatory Policy leadership team. Liaise with other GSK policy and government affairs staff and internal stakeholders to ensure aligned GSK positions are presented to the external environment
• May provide staffer support to senior leaders in support of key external meetings and trade association committees
• May take global responsibility for a policy priority topic, e.g., RWE, expedited regulatory pathways

Why you?

Basic Qualifications:

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

• Bachelor’s degree in life sciences
• 7+ years experience in a regulatory affairs function/role, with a command of all phases of the drug development process
• 7+ years of experience in regulatory policy and advocacy or similar role

Preferred Qualifications:

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

• Master’s degree, PhD, PharmD, or JD
• Excellent interpersonal skills.
• Leading, developing and motivating a team
• Deep understanding of US external regulatory environment
• Strong and effective internal and external networks
• Ability to present clearly and effectively to a variety of audiences, internally and externally.
• Excellent influencing and negotiation skills with internal and external stakeholders from different cultures anticipating and managing objections and challenges
• Leading, coaching and motivating a team
• Highly skilled at analyzing and interpreting complex information; proven ability to assimilate and summarize information accurately in a clear and concise manner. Able to think creatively to manage and leverage information relating to regulatory precedents.
• Significant knowledge of drug development process and laws, regulations and practices affecting the biopharmaceutical industry in the region
• Working in a global matrix, able to navigate regional and global needs

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 di