Associate Director, Global Regulatory Affairs, Precision Medicine

3 weeks ago


Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time
Purpose

Develop and execute a comprehensive regulatory strategy for Precision Medicine and Digital Health assets across the GSK therapeutic portfolio, ensuring compliance with internal processes and regional regulatory requirements.

Responsibilities and Accountabilities

The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for developing and delivering regional Precision Medicine and Digital Health regulatory strategies. This role will involve extensive matrix working within GSK, representing the company with Precision Medicine/Digital Health partners and regulatory agencies, and leading or participating in interactions with local/regional regulatory authorities.

Key responsibilities include:

  • Developing and executing global Precision Medicine and Digital Health regulatory strategies
  • Leading regulatory interactions and review processes for GSK
  • Ensuring compliance with regulatory requirements at all stages of product life
  • Advocating for regulatory approaches to senior leaders in GSK and Health Authorities
  • Providing assessments of Precision Medicine and Digital Health components for potential in-license molecules
Basic Qualifications

We are seeking professionals with the following required skills:

  • BS in biological science, healthcare science, or engineering
  • Experience in regulating companion diagnostics and SaMD within a pharmaceutical company
  • Leadership experience in global development, submission, and approval activities
  • Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in all major countries
Preferred Qualifications

Preferred qualifications include:

  • Excellent communication skills, with the ability to deliver key messages with clarity, impact, and passion
  • Proven ability to build strong personal networks and secure support and outcomes for projects
  • Ability to recognize and resolve conflict, and arbitrate as necessary
  • Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions


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