The Manager, Regulatory Operations reports into the Senior Program/Project Manager of Regulatory Affairs who has global purview within the organization. The Department of Regulatory Affairs oversees units of Medical/Scientific Writing and Pharmacovigilance and interfaces closely with Clinical and Manufacturing departments. This position is pivotal in maintaining organization’s direct lines of communication for, interactions with, and access to Regulatory Authorities/Agencies in the US and abroad. The individual who fills this role should enjoy a multi-cultural work environment with colleagues in the US and abroad.
Primary responsibility is to manage and oversee the publication and submission of eCTD FDA/EMA/ROW compliant documents/dossiers and communications to Agencies/Authorities in support of the development of products, new biological entities and manufacturing production platforms, product lifecycle management activities, post approval obligations and submission/file maintenance for regulatory activities leading up to product approval and product commercialization and subsequent post-approval tasks for all product regulatory obligations and compliance tasks.
BS degree in relevant/related discipline/industry preferred
4+ (or suitable equivalent) years of Regulatory Operations/Submissions experience in a CRO/biotech/pharmaceutical company
Strong regulatory operations, eCTD, and submission technical capabilities are required.
Internal Number: 001
About LFB USA
LFB USA is a privately held biotechnology company with headquarters and laboratories in Framingham, MA and manufacturing operations in Charlton, MA.
At LFB USA we are empowering the development and commercialization of highly innovative recombinant therapies to address an ever-growing set of unmet medical needs. To do this effectively, we challenge ourselves to think differently and to confront challenges with a focused determination. Our deep appreciation for and understanding of science is paramount. But of equal importance is our commitment to applying science purposefully and with the greatest sense of responsibility. Why do we do what we do? Because people depend upon us: practitioners, patients, and families. All with the same aspiration of providing for and leading full lives in good health. Our efforts are aligned with this pursuit. In fact, we know we can have a direct effect on people's lives through what we do as a company. This is what drives everyone at LFB USA. We are all here today to ensure a better tomorrow.