SUMMARY OF POSITION:
The Manager of Regulatory Affairs is responsible for developing and implementing regulatory strategies for assigned drug products throughout product lifecycle. He/she will help lead regulatory in support of Mallinckrodt Pharmaceuticals’ efforts to obtain approvals to market new generic drug products and provide ongoing regulatory support for all post-marketed projects and programs, ensuring maintenance and regulatory compliance of marketed generic drugs. The Manager of Regulatory Affairs will be a key member of project teams, responsible for evaluation of product concepts and opportunities from the regulatory perspective.
The current opening is for a Manager of Regulatory Affairs in the Post-Approval Submissions group, and the focus will be management of approved ANDAs. Pre-Approval ANDA management will also be required on an as-needed basis.
Evaluate proposed changes to approved products for potential Regulatory impact and gather required data as needed to defend a Regulatory filing strategy
Provide regulatory risk assessments and intelligence on CMC, clinical and safety reporting related regulatory issues, both internally and with external partners.
Manage, prepare, publish using eCTD software well-organized, scientifically sound CMC and safety-related regulatory submissions which include ANDAs, Amendments, Annual reports, PSUR and Supplements that comply with applicable regulatory requirements in eCTD format
Coordinate and communicate timelines and deliverables with Regulatory Operations, Labeling and other key departments to facilitate quality CMC and safety-related regulatory submissions, including ANDAs, Amendments, Annual reports, PSUR and post approval Supplements.
Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.
NON-ESSENTIAL/DEPARTMENT SPECIFIC FUNCTIONS:
Other duties as assigned with or without accommodations.