Regulatory Affairs | API

Ami Lifesciences; Vadodara; On-site; INR 550,000 - 750,000; Full time

Job summary

Ami Lifesciences in Vadodara invites a Regulatory Affairs professional to lead preparation, review and submission of regulatory dossiers (DMF, CEP) and to handle regulatory queries and deficiency responses. You will ensure documentation complies with global requirements and support cross-functional teams (R&D, QA, QC, Production).

Ideal candidates hold an MSc in Organic/Analytical Chemistry or an M.Pharma, with 2–10 years in the API industry, and have strong knowledge of international regulatory

Qualifications

• MSc in Organic/Analytical Chemistry or M.Pharma required.
• 2–10 years of API industry experience preferred.
• Knowledge of regulatory guidelines and quality systems advantageous.

Responsibilities

• Preparation, review and submission of regulatory dossiers (DMF, CEP, etc.).
• Handling regulatory queries and deficiency responses.
• Compilation and review of technical documents per global requirements.
• Coordination with R&D, QA, QC, Production teams.
• Ensuring compliance with international regulatory guidelines.

Education

M.Sc. Organic Chemistry

M.Sc. Analytical Chemistry

M.Pharma

Job description

Role & responsibilities

• Preparation, review, and submission of regulatory dossiers (DMF, CEP, etc.)
• Handling regulatory queries and deficiency responses
• Compilation and review of technical documents in line with global requirements
• Coordination with cross-functional teams (R&D, QA, QC, Production)
• Ensuring compliance with international regulatory guidelines

Preferred candidate profile

• M.Sc. Organic / Analytical Chemistry / M.Pharma
• 2 to 10 years of experience in API Industry