US Regulatory Policy Director

25 Jul, 2021


US Regulatory Policy Director

Research Triangle Park, NC

Are you looking for a highly visible regulatory leadership role where you can drive the regulatory policy, advocacy and intelligence activities for assigned topics to ensure optimal advancement and life cycle management of GSK’s biopharmaceutical portfolio? If so, this Regulatory Policy Director role could be an exciting opportunity to explore.

As a Regulatory Policy Director, you will be responsible for actively supporting the shaping of the regulatory environment to enable GSK to influence and respond to strategic regulatory changes in the external environment in a compelling, science driven manner for assigned topics. This individual will utilize their external and internal stakeholder network to enable GSK advocacy activities

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

  • Development and maintenance of the assigned US regulatory policy, advocacy and intelligence priorities and activities 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 assigned topics.
  • Lead the development and implementation of plans and actions for assigned topics to influence regulatory opinion leaders in the external environment.
  • Influence the adoption of appropriate implementation activities for assigned topics within GSK participating in specific GRA implementation teams to address major legislative changes as required
  • Build and maintain links with key external stakeholders and networks including regulatory agencies, governments, trade associations
  • Represent GSK and/or trade associations at key Agency, Industry and trade association meetings
  • Liaise with other GSK policy and government affairs staff and internal stakeholders to support development of aligned GSK positions.
  • May be a member of the Regulatory Intelligence matrix led by the Head Regulatory Intelligence Systems.
  • 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

Why you?

Basic Qualifications:

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

  • Bachelor’s degree
  • 5 or more years industry Regulatory Affairs experience
  • 5 or more years leading matrixed teams across global regions

Preferred Qualifications:

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

  • PhD or Masters’ degree in life sciences or pharmacy
  • Strong technical knowledge required to be able to assess regulatory compliance of products
  • Ability to interact with regulatory officials and support advocacy initiatives

Why GSK?

Our values and expectations are 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, rigour 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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Job posted: 2021-07-25