$80K — $100K *
Responsible for CMC regulatory functions, the Senior Manager/Manager, CMC Regulatory will collaborate cross- functionally to help develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s) globally. Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products. This position will assist in the preparation and filing of regulatory CMC submissions and support company interactions with all Health Authorities for CMC topics. This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
This is an office-based position, remote option will not to be considered.
Essential Job Functions/Responsibilities
· Combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation
· Lead the preparation and review of CMC sections of early phase (Ph1-2) regulatory submissions (IND/IMPD), as well as the interactions and responses with regulatory agencies
· Utilize understanding of GCP, GMP, and GLP to advise teams regarding these and other country-specific health authority regulations
· Advise teams regarding development activities and documentation needed for a successful marketing application, as needed
· Provide CMC regulatory guidance to cross-functional teams and key stakeholders, including external partners
· 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
Required Education & Qualifications
Valid through: 8/14/2020