Offer summary
Qualifications:
University degree in life sciences, 8-15 years of regulatory affairs experience, Experience in global filing plans, Strong leadership and motivation skills, Proficiency in Veeva Vault and other systems.Key responsabilities:
- Develop global regulatory strategies for submissions
- Identify risks and mitigate impacts on timelines
- Lead detailed preparation of regulatory plans
- Coordinate filing teams and respond to regulators
- Manage MA maintenance activities as needed