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Regulatory Affairs Specialist
2 semanas atrás
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with all relevant laws and regulations.
About the RoleThe successful candidate will have a strong background in regulatory affairs, with experience in planning, preparing, and submitting regulatory processes required for business continuity. You will also be responsible for delivering pre-filing requirements, preparing registration renewal, HMP, and regulatory low-mid complexity filings without major supervision. Additionally, you will assist on preparation of major filings under certain supervision, like BLA, NDA, LCM, and DDCM, according to pipeline submission plans tightly aligned with the endorsed strategy and targeted timelines.
Key Responsibilities