CMC Regulatory Project Manager
Job Title: CMC Regulatory Project Manager
Duties: Committed to a vision of harnessing RNA interference for human health with the goal of developing and commercializing RNAi therapeutics for patients in need. Following the submission of the NDA and MAA applications for our lead candidate, patisiran, we are seeking a CMC Regulatory Project Manager, who will manage all aspects of CMC responses to questions from the FDA, MAA and PMDA, in close partnership with CMC Regulatory Affairs Lead. • Partner primarily with Regulatory Affairs CMC lead to manage all RA CMC submission related activities for patisiran.
Manage CMC activities for the preparation of patisiran marketing applications including JNDA, NDS, and applications for other geographies as identified by patisiran leadership team
Identify and partner with required SMEs in each expertise area in Technical Operations and Quality (TOQ) and other EAs as needed to oversee execution of action plans
Schedule and conduct meetings with SMEs for the various workstreams as needed, to progress the completion of the filings Manage the review cycles and any follow up round tables as needed per the filing timelines Develop agendas and issue minutes and action items for submission team meetings
Skills: • CMC and/or regulatory experience in drug development and regulatory submissions required; experience in product registration strongly desired. Experience as a member of a cross-functional team strongly preferred.
• Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities and drive results • Exceptional organizational skills and ability to handle complexity • Must be fluent in English (written and spoken)• Demonstrated competence in written and verbal communication • Must be proficient in the use of MS Word, Excel, Power Point and MS Project, in particular required • Minimum of 5 years of experience in pharmaceutical or biotechnology industry
Education: • Bachelor’ s degree in sciences or related field required Skills and Experience: