A company is looking for a Senior Manager, Regulatory Project Management.
Key Responsibilities
Lead regulatory-focused project management activities across the R&D product lifecycle, including global expansion
Develop and optimize detailed regulatory project plans and timelines in collaboration with relevant teams
Maintain real-time filing timelines and track key submissions and deliverables for regulatory applications
Required Qualifications
Bachelor's degree in life sciences, pharmacy, or related field preferred with at least 6 years of experience in regulatory affairs or project management
Demonstrated project management skills with a strong ability to prioritize multiple projects
Proficiency in project management tools and content management systems
Experience managing global regulatory submissions for investigational and marketing applications
Understanding of regulatory processes and requirements, with experience interpreting Health Authority guidelines
Senior Project Manager • Louisville, Kentucky, United States