My client is an established mid-sized global biopharma company with a presence in over 30 countries that has grown their global regulatory team from 7 to 21 people in the last twelve months. As the Global Regulatory Lead you will be responsible for providing strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for assigned projects. This is a great opportunity for you to jump right into this established collaborative, science driven environment and hit the ground running!
Responsibilities:
- Lead the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure alignment of the regional and CMC regulatory strategies with the global regulatory strategy.
- Responsible for regulatory strategic decision making necessary to ensure planning and execution of successful global regulatory strategies, submissions and approvals for assigned projects.
- As the primary regulatory interface, the incumbent will have responsibility for ensuring collaboration with key internal stakeholders of the Core Project Team (CPT) and the Clinical Development Team (CDT) to ensure successful planning and execution of the global regulatory strategy for assigned projects.
- Pro-actively support the regional strategic leads on the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned therapeutic areas and products.
Knowledge and Skills:
- Minimum BS in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science required. MS/MBA, PhD, or MD preferred
- Minimum of 8 years’ experience in the biotech or pharmaceutical industry with at least five years in Regulatory Affairs
- Prior experience managing regulatory submissions (INDs, CTAs, BLAs, MAAs) in the US and EU.
- Must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan).
- Experience working in Regulatory Affairs in a global environment across two or more geographic areas (preferentially US and EU).
- Ability to drive regulatory strategy development
- Must be a strong leader