Director, Global Regulatory Affairs, Precision Medicine

Vor 4 Tagen

Zug, Schweiz TN Switzerland Vollzeit

Director, Global Regulatory Affairs, Precision Medicine & Digital Health, Zug

Client: 1925 GlaxoSmithKline LLC

Location: Zug

Job Reference: ff5fb170779d

Job Views: 14

Posted: 22.01.2025

Expiry Date: 08.03.2025

Job Description:

Purpose:

Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.

Responsibilities and Accountabilities:

  1. Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery.
  2. In this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies. This role works closely with members of the Experimental Medicine Unit and Digital Health teams. Lead or participate in interactions with local / regional regulatory authorities.
  3. Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. Leading regulatory interactions and the review processes for GSK.
  4. Ensuring compliance with regulatory requirements at all stages of product life from C2MD.
  5. Advocate persuasively approaches to senior leaders in GSK and in Health Authorities.
  6. Provide assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules.

Competencies and Capabilities:

  1. Challenges and questions ways of working to seek improved process.
  2. Establishes team goals and uses them to seek to improve performance, with ability to set challenging but realistic targets.

Basic Qualifications:

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

  1. Master’s Degree in biological science, healthcare science, or engineering.
  2. Experience in regulation of companion diagnostics and SaMD.
  3. Led global development, submission, and approval activities. Organized and executed milestone meetings.
  4. Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in all major countries.

Preferred Qualifications:

  1. Excellent communication skills, ideally in writing and verbally.
  2. Proven ability to foster strong matrix working.
  3. Ability to lead change and communicate difficult messages.
  4. Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project.
  5. Ability to proactively recognize and resolve conflict and arbitrate as necessary.
  6. Proven ability to take sound decisions, often without complete information.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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