Principal Scientist (Director), Regulatory Affairs-CMC

Job description

Job Description GRACS CMC – Principal Scientist, CMC, – Pharm Pre-approval (Inhalation/Respiratory Franchise) Reporting to the Ex-Director/ Sr. Director in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance’s, with focus on small molecule respiratory/inhalation product development. Position will primarily lead oversight of multiple programs in Respiratory franchise and some conventional small molecule programs. Primary responsibilities include, but are not limited to the following: Primary Responsibilities Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products. This includes preparation of applicable IND/CTA’s, Agency Background Packages, Worldwide Marketing Applications (including Most of World applications), and transfer strategy to post-approval grp. for further submissions occurring within several years post-launch in the major markets. This role may also directly su...