Senior Director & Head, US Regulatory Policy

Research Triangle Park, North Carolina; Rockville, Maryland; Collegeville, Pennsylvania
February 09 2021
Organization Type
Are you looking for a highly visible, strategic regulatory leadership role where you can accelerate regulatory innovation for a leading global biopharmaceutical company? A role where you have the opportunity to shape and drive the direction for a new US regulatory policy team, aligned with our global regulatory policy priorities? If so, this Head, US Regulatory Policy role could be an exciting opportunity to explore.

The role is responsible for the leadership of a team focused on defining and driving 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 in a compelling, science driven manner. Utilize your deep understanding of the US regulatory environment and extensive external and internal stakeholder network to enable GSK advocacy activities and proactively drive key opportunities to advance GSK's biopharmaceutical portfolio.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • 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;
  • 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
  • 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
  • Provide support to senior leaders in support of key external meetings and trade association committees

Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelors or advanced degree in appropriate scientific discipline
  • 8+ years experience in the pharmaceutical/biopharm industry, with extensive experience in a regulatory affairs function/role , with significant knowledge of drug development process and US laws, regulations and practices affecting the biopharmaceutical industry in the region
  • Excellent interpersonal and communication skills. Proven ability to communicate (written/oral) with clarity, impact and passion.
  • Demonstrated ability to present clearly and effectively to a variety of audiences, internally and externally
  • Experienced and highly skilled at analyzing and interpreting complex information
  • Experience proactively driving opportunities aligned to business objectives
  • Experience in regulatory policy and advocacy or similar role
  • Experience leading, developing and motivating a team
  • Demonstrated deep understanding of US external regulatory environment

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • MSc, PhD, JD, PharmD or Regulatory Affairs post graduate qualification
  • Excellent influencing and negotiation skills with internal and external stakeholders from different cultures anticipating and managing objections and challenges
  • Strong and effective internal and external networks
  • Working in a global matrix, able to navigate regional and global needs

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.


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