Lead the execution of multi-product global regulatory CMC strategies for investigational and marketed products in US, EU, and other International regions. Lead the preparation and filing of regulatory CMC submissions and manage the interactions with Health Authorities for CMC topics.
Provide regulatory support and guidance to various cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
Lead the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
Develop global CMC regulatory strategies for one or more investigational and/or marketed products
Collaborate with US & International regulatory colleagues in development of global CMC regulatory strategies and submissions
Provide CMC regulatory guidance to cross-functional teams and key stakeholders
Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Work effectively on cross-functional teams and be the primary regulatory CMC contact for assigned products and projects
BA/BS/University degree in Life/Health Sciences required; advanced degree preferred
7+ years of pharmaceutical or biotech industry experience
5+ years of regulatory affairs CMC experience (or relevant experience)
Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Experience in leading the preparation, including writing, CMC submissions
Strong communication skills, including both written and oral
Strategic thinking and strong problem solving skills
A collaborative individual, who listens effectively and invites response and discussion who communicates in an open, clear, complete, timely and consistent manner
Strong sense of planning and prioritization, and the ability to work with all levels of management
Capable of strategic thinking with ability to resolve complex and ambiguous situations, understanding the scientific principles and regulatory requirements.
In-depth knowledge of cGMP, FDA, EMA, ICH, highly desirable to have global experience in Latin America and other regions.
Experience with Quality by Design (QbD) filings, post-approval maintenance, change controls, Trackwise and establishment registration requirements
Understanding of the end-to-end drug development process