Manager, Regulatory Operations

Manager, Regulatory Operations

Cambridge, MA






Molecular Insight Pharmaceuticals, Inc., located in Cambridge, MA, is a growing biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve patient healthcare by addressing significant unmet medical needs. We currently have a great opportunity for a highly motivated professional and creative thinker to report to the Director, Regulatory Affairs, the Manager, Regulatory Operations and oversee the production, management, archiving, and indexing of regulatory submissions, in both electronic and hard-copy formats, for R&D projects and commercial products.




Specifically you will: Schedule, manage, and set priorities for the compilation, publishing, distribution, and archiving of electronic and paper regulatory submissions (IND, NDA, MAA, Orphan Drug Applications) and regulatory communications (incoming and outgoing) Manage the systems and software used in the production, submission and archiving of electronic submissions Manage the maintenance of and access to the official corporate regulatory archives; ensure that all archived documents are maintained in a manner that will support FDA on-site inspections and due-diligence activities Interface with, manage, and set priorities for the RA documentation activities of contract research organizations contracted to compile and publish major electronic and paper regulatory submissions and/or to provide components of these documents Establish, update, implement, and provide training on RA Operations formats, templates, policies, standards, and procedures for regulatory documentation Represent RA Operations in submissions planning meetings of project teams and advise the teams on the timelines and process for regulatory submissions publishing; prepare and maintain submission tracking documents and monitor status of submission components Review and provide advice on the structure and preparation of regulatory submissions Maintain up-to-date knowledge of FDA standards and procedures for regulatory submissions, including eCTD and PLR/SPL; analyze new and revised guidance, advise Regulatory management of new requirements, and recommend course of action Plan and implement on-site storage space solutions for regulatory archives, in conjunction with Facilities group Manage vendors contracted to provide permanent off-site document storage, and manage the transfer and retrieval of RA documents stored off-site Manage, train, and evaluate Regulatory Documentation Assistants, Coordinators, and Specialists




This position requires: 3-5 years experience in Regulatory Affairs/Regulatory Operations with a strong background in electronic submissions Excellent negotiation, problem-solving, organizational, and written/verbal communication skills PC proficiency with MS Office




Molecular Insight Pharmaceuticals offers competitive compensation & benefits. If you thrive in an entrepreneurial, stimulating environment where initiative and individual contributions are valued, recognized and rewarded, we’d like to hear from you. Please email your resume to: careers@molecularinsight.com Equal Opportunity/Affirmative Action Employer M/F/D/V. No phone calls please.




To view the complete job description, please visit:
www.molecularinsight.com