Senior Executive, Regulatory Affairs

Amneal; Gujarat; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal in Gujarat, India, seeks an experienced Regulatory Affairs Scientist to scientifically review external API vendor DMFs within the global ANDA/NDA context and address gaps. The role involves preparing and reviewing Drug Substance Modules for FDA submissions and related activities.

You will participate in cross-functional project meetings, coordinate with teams, and support Europe and Canada markets for the drug substance portion as required.

Qualifications

• Knowledge of current regulatory guidelines.
• Experience with complex APIs.
• Knowledge of using AI in routine work.

Responsibilities

• Scientific review of external API vendor's DMFs in context of global ANDA/NDA and resolve 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.

Skills

Regulatory guidelines

Complex APIs

AI in workflow

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.