Senior Executive, Regulatory Affairs
Senior Executive, Regulatory Affairs
Refined job description
ROLE
– Scientific review of external API vendor’s DMFs in context of global ANDA/NDA and resolve any gaps.
– Prepare and review ANDA/NDA Drug Substance Modules for submission to the FDA and related activities.
– Participate in project meetings, coordinate with cross‑functional teams, and ensure effective communication.
– Support Europe and Canada market projects for the drug substance portion as required.
REQUIREMENTS
– Knowledge of current regulatory guidelines.
– Experience with complex APIs.
– Knowledge of using AI in routine work.
– Preference for local candidates.
Full job description
JD:
Scientific review of external API vendor’s DMFs in context of global ANDA/NDA & resolving any gaps.
Preparation & review of ANDA/NDA Drug Substance Modules for submission to FDA & related activities.
Participation in project meetings, coordination with CFTs, effective communication & coordination.
Supporting Europe & Canada market projects for Drug substance part, as required.
Knowledge of current regulatory guidelines is required.
Experience of complex APIs will add value.
Knowledge of using AI in routine work will add value.
Local candidate is preferred.