Global Regulatory Therapeutic Lead
My client is an established global biopharma company that has retained us to fill a growth opportunity for a Global Regulatory Therapeutic Lead to join their science driven, patient focused culture. In this newly created role you will be leading strategy (US and Global) for assigned programs in development through commercialization, while working closely with Senior Management. This is a highly visible role where you will be collaborating with a number of cross-functional stakeholders both internally and externally.
Responsibilities:
- Leading interactions with local / regional regulatory authorities
- Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally
- Implementing regional strategy(s) in support of the project globally
- Leading regulatory interactions and the review processes in local region, as assigned
- Ensuring appropriate interaction with regional commercial teams in local region
- Ensuring compliance with regional requirements at all stages of product life
- Facilitating dialogue between team and matrix members so they understand links between their different ideas and perspectives
- Bringing team members into the discussion so they can contribute their ideas
- Developing and recommending strategies for change
Knowledge and Skills:
- Minimum BS/BA required; PhD or MD Preferred
- 10 years of experience with at least 5 within Global Regulatory
- Experience of all phases of the drug development process in regulatory affairs
- Capable of leading regional development, submission and approval activities in local region(s)
- Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally
- Knowledge of relevant area of medicine, and ability to further develop necessary specialist knowledge for the product or area of medicine
- Must work well in a matrix environment