about 2 months ago
Senior Manager, CMC – Los Angeles
- Collaborate with partner companies to address strategy and content of initial submission as well as and life cycle management of regulatory submissions (e.g. IND, CTA, NDA, and MAA).
- Provide knowledge of global and local regulations so that regulatory submissions are in compliance with requirements
- Identify risk areas and develop alternative plans of action through development of contingency plans
- Ensure CMC regulatory strategy coincides with regulatory and business strategy
- Communicate CMC changes to partner companies
- Lead and coordinate the creation and critical review of the data packages from other representatives in order to provide complete necessary documentation necessary
- Lead technical task force meetings leading on RA and CMC related activities.
- Bachelor’s degree and 8+ years of relevant experience required
- Advanced degree (MS/PhD) and 6+ years’ experience also acceptable.
- Organizational skills – detail oriented and can deal with frequent changes in product activity
- High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our small, but growing environment
- Ability to adapt in a constantly evolving environment
- Familiarity with Cellular Therapy regulatory requirements in AsiaPac is highly preferred