Lead the development of appropriate business-focused, high-quality, timely regional regulatory strategy and its execution for assigned asset(s)
Responsible for the development of optimal regional regulatory strategy and for its delivery according to plan
Provide deep regulatory knowledge and international markets expertise
Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective
Proactively develop and implement regional regulatory strategy aligned with enterprise goals and local opportunities
Represent Regulatory function in collaboration with regional stakeholders
Drive early engagement with LOC RAs proactively sharing knowledge on clinical development programs and key project milestones

Bachelor Degree in a scientific discipline such as life sciences, pharmacy, medicine, or equivalent
Proven experience of leading regional development, submission and approval activities in region(s) and/or globally
Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
Extensive experience of all phases of the drug development process in regulatory affairs
Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally
Extensive knowledge of relevant areas of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area

Regional Regulatory Affairs Director – International

Key skills