| As the senior member of Technical/CMC regulatory affairs (RA) team, this position will be responsible for ensuring the adequacy of required Chemistry, Manufacturing and Controls (CMC) documentation for global regulatory submissions (IND, NDA/MAA) for human pharmaceutical products. Essential Duties and Responsibilities include the following. Other duties may be assigned: Lead CMC RA team in the creation of CMC submissions to FDA (including INDs and NDAs and post approval Supplements) and to support their approval by FDA.
Provide CMC regulatory guidance on development projects, and for post approval CMC changes, define CMC regulatory submission strategy during development and post-approval.
Ensure that the CMC information in companys regulatory submissions are in compliance with applicable laws and federal regulations.
Responsible for direct communications with regulatory authorities on all CMC related issues and responsible for ensuring implementation of commitments made and implied by those interactions
Assist with the scientific writing and review of IND, NDA/MAA, and their amendments and evaluate conformance with the regulatory requirements.
Manage timelines in cooperation with project management on assigned projects.
Provide progress updates to senior management in regulatory development projects Supervisory Responsibilities:
Recruit and hire CMC regulatory team
Supervise, coach, and develop the skills of CMC RA team who report directly to this position.
Assign /monitor work of subordinates to ensure quality, consistency, and timeliness of work | 
