Description
Are you a Regulatory Affairs professional looking to expand your career in Precision Medicine and Digital Health? If yes, then this Associate Director/Director role may be for you!
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 (include expected deliverables, managerial and leadership responsibilities and performance standards)
- 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.
- 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.
Roles and Responsibilities
- 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.
- Ensuring compliance with regulatory requirements at all stages of product life from C2MD.
- Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities.
- Capable of providing assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules.
- Competencies and Capabilities (include key high performance behaviors). Challenges and questions ways of working to seek improved process.
- Establishes team goals and uses 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:
- Bachelor's degree in biological or healthcare science.
- Three or more years of experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD, including for projects with little or no precedence.
- Three or more years of experience of leading global development, submission and approval activities.
- Three or more years of experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in all major countries and ideally sound knowledge globally.
Preferred Qualifications
If you have the following characteristics, it would be a plus
- PhD in a biological or healthcare science.
- Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority.
- Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion.
- Commands attention and interest through use of appropriate communication techniques. Proven ability to foster strong matrix working.
- Capable of facilitating groups of individuals to work together on creating solutions. Ability to lead change and communicate difficult messages.
- Able to implement plans and hold self and team accountable for delivery of short and medium term goals.
- Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project, developing an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
- Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
- Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
- Proven ability to make sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints.
In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions.
