96755 - Sr. Associate, Regulatory Affairs US-Massachusetts-Boston

Job Description:Responsible for assisting in the development and implementation of regulatory strategy for specific projects, represent Regulatory Affairs on relevant project teams, and assisting in the planning, coordination and preparation of regulatory submissions.Duties and Responsibilities:A. Essential Functions:•Responsible for assisting in the development and implementation of regulatory strategy for assigned projects and programs.•Responsible for assisting in the planning, coordination and preparation of regulatory submissions relevant to assigned projects or programs.•Prepare and deliver effective presentations for external and internal audiences.•Contact regulatory agencies relevant to assigned projects or programs, as appropriate.•Represent regulatory on relevant project teams, as appropriate.B. Additional Functions:•Take steps to actively improve interdepartmental communications.•Assist in the evaluation of proposed CMC changes.•Assist in global submission planning and tracking.•Assist in the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).•Form strong relationships with distributors and commercial teams.•Assist in the ROW filing strategy for new submissions.



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96755 - Sr. Associate, Regulatory Affairs US-Massachusetts-Boston