Director, Regulatory Affairs, Precision Medicine & Digital Health
GSK
4 months ago
Remote friendly (Waltham, MA)
United States
Corporate Functions
Position Summary:
- Lead regulatory strategy for precision medicine and digital health across respective regions.
- Work with scientific, clinical, digital and commercial teams to design and deliver regulatory plans enabling safe, effective, 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.
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:
- 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.
- Lead regulatory strategy for precision medicine and digital health across respective regions.
- Work with scientific, clinical, digital and commercial teams to design and deliver regulatory plans enabling safe, effective, 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.
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:
- 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.