Work as US Regulatory Lead as directed for portfolio of assigned projects. Liaise with global leads for Biopharma Regulatory Affairs (RASB) as required to develop and implement US regulatory strategies for complex projects.
Work independently under limited supervision in complex matrix environment. Apply in-depth understanding of CFR, FDA and ICH guidelines and cGMPs pertaining to development, licensure and marketing of drugs and biologics. Provide regulatory guidance, critically review documents for submission to FDA, and ensure execution of US regulatory strategy for projects in line with global project team goals.
Represent US RASB on cross-functional project teams and provide strategic regulatory guidance throughout research, development, launch and post-approval process as required. As FDA liaison contact for assigned projects, lead preparation and conduct of FDA project meetings and major label negotiations with FDA. Responsible for projects through all phases of development, post-approval and life cycle management (i.e. original submissions, amendments, responses to action letters, supplements, annual reports, other life cycle management regulatory submissions to FDA). Ensure project regulatory strategy aligns with target product profile (TPP), US biosimilar regulatory environment, US organization needs (Commercial, Medical, IP) and global development strategy.
Coordinate and lead development of regulatory strategies for new medical devices as part of combinational product registration for injectable biologics. Coordinate efforts associated with regulatory submissions relevant to assigned projects and programs, including IND, BLA, and major Supplements. Critically review technical and scientific submission documents.
Interact with key scientific, clinical research, and commercial personnel within and outside company as needed to ensure timely, accurate regulatory compliance. Identify issues, gaps and trade-offs, and assess regulatory risks associated with product development. Define strategies to mitigate risks and influence line functions to implement them.
Maintain awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to biosimilar products and understand the impact on current and future submissions. Mentor regulatory staff on assigned products and regulatory process-related topics. Lead work plans and provide direction to regulatory associates. Create schedules and work plans for monitoring, compiling and submitting filings consistent with company standards.