Director, Regulatory Affairs, Precision Medicine & Digital Health
GSK
4 months ago
Remote friendly (Durham, NC)
United States
Corporate Functions
Position Summary:
You will lead regulatory strategy for precision medicine and digital health across respective regions, designing and delivering regulatory plans that enable safe, effective and compliant development.
Responsibilities:
- Lead development and execution of regional regulatory strategies for precision medicine and digital health assets.
- Coordinate regulatory interactions with local and regional health authorities and external partners.
- Provide regulatory input to cross-functional project teams from early development through lifecycle management.
- Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components.
- Interpret regulatory feedback and translate it into clear operational plans and submission materials.
- Mentor and coach colleagues to build regulatory capability across the business.
Basic Qualifications (Required):
- Bachelor’s degree in biological science, healthcare science, engineering or equivalent.
- Experience working in the pharmaceutical industry, MedTech industry or regulating authorities.
- Practical experience with regulation of companion diagnostics and/or SaMD.
- Proven track record leading development, submission and approval activities in one or more regions.
- Experience preparing for and leading regulatory milestone meetings and authority interactions.
- Strong written and verbal communication skills and ability to work in a matrix environment.
Preferred Qualifications:
- Advanced degree (MSc, MS, PhD, MD or equivalent) in a relevant discipline.
- Deep knowledge of clinical trial and licensing requirements for precision medicine and digital health across major markets.
- Experience influencing senior stakeholders and advocating regulatory positions.
- Proven ability to build cross-functional networks and external relationships.
- Practical experience assessing in-licensing opportunities involving diagnostic or digital components.
- Experience coaching or developing junior regulatory professionals.
Application Instructions:
- Submit your CV and a short cover letter explaining how your experience matches the role.
On-site Requirement:
- On-site office-based presence 2–3 days/week in the US (MA, MD, PA or NC), UK (London or Stevenage), or Poland (Warsaw).
You will lead regulatory strategy for precision medicine and digital health across respective regions, designing and delivering regulatory plans that enable safe, effective and compliant development.
Responsibilities:
- Lead development and execution of regional regulatory strategies for precision medicine and digital health assets.
- Coordinate regulatory interactions with local and regional health authorities and external partners.
- Provide regulatory input to cross-functional project teams from early development through lifecycle management.
- Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components.
- Interpret regulatory feedback and translate it into clear operational plans and submission materials.
- Mentor and coach colleagues to build regulatory capability across the business.
Basic Qualifications (Required):
- Bachelor’s degree in biological science, healthcare science, engineering or equivalent.
- Experience working in the pharmaceutical industry, MedTech industry or regulating authorities.
- Practical experience with regulation of companion diagnostics and/or SaMD.
- Proven track record leading development, submission and approval activities in one or more regions.
- Experience preparing for and leading regulatory milestone meetings and authority interactions.
- Strong written and verbal communication skills and ability to work in a matrix environment.
Preferred Qualifications:
- Advanced degree (MSc, MS, PhD, MD or equivalent) in a relevant discipline.
- Deep knowledge of clinical trial and licensing requirements for precision medicine and digital health across major markets.
- Experience influencing senior stakeholders and advocating regulatory positions.
- Proven ability to build cross-functional networks and external relationships.
- Practical experience assessing in-licensing opportunities involving diagnostic or digital components.
- Experience coaching or developing junior regulatory professionals.
Application Instructions:
- Submit your CV and a short cover letter explaining how your experience matches the role.
On-site Requirement:
- On-site office-based presence 2–3 days/week in the US (MA, MD, PA or NC), UK (London or Stevenage), or Poland (Warsaw).