Vacancy Description
Responsibilities:
Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology, HIV and liver disease.
The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities.
May serve as regional lead on cross-functional/ cross-regional Regulatory Submission Teams.
Responsible for preparing and submitting regulatory documents which require interaction with departments in and outside of Regulatory Affairs CMC for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Examples include original INDs, NDAs, BLAs, amendments, supplements, annual reports and license renewals.
Performs document filing and retrieval f...