Description
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.
Responsibilities and Accountabilities:
- 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.
- 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.
Basic Qualifications:
- Bachelor’s degree in biological or healthcare science.
- 5+ years experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD, including for projects with little or no precedence.
- Experience of leading global development, submission and approval activities (FDA).
- Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority, additional experience ex US and EU preferred.
- Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in major countries and ideally sound knowledge globally.
Benefits:
- Annual base salary ranging from $171,750 to $286,250.
- Annual bonus and eligibility to participate in share-based long-term incentive program.
- Health care and other insurance benefits (for employee and family).
- Retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
For more fresh new jobs, check out yubhub.co.