Hetero Drugs looking for Regulatory Affairs Executive - M.Pharm, B.Pharm, MSc Apply

Hetero Drugs One of world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector. We endeavour to serve patients by moulding science and technology into therapies to improve health outcomes and people’s lives.

Post : Executive

Department : Regulatory Affairs - API
Experience : 2-5 years of experience in Regulatory Affairs within the API industry.

Qualification : M.SC (Organic Chemistry) / M.PHARMA (Pharmaceuticals) B.PHARMA (Pharmaceuticals)

Summary : The ideal candidate will be responsible for compiling Drug Master Files (DMFs) and Certificates of Suitability (CEPs), ensuring compliance with global market regulations and emerging market standards in accordance with ICF guidelines. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports.

Key Responsibilities
• Prepare and submit regulatory dossiers for emerging and global markets, including Brazil, China, LATAM, US, EU, and ICH regions.
• Stay updated with evolving regulatory requirements and implement changes in documentation
• Handle regulatory filings, including annual updates and amendments.
• Participate in deficiency meetings, review pending deficiencies, and collaborate with cross-functional teams to ensure timely submission of responses.
• Review documents, identify gaps, ensure compliance, and facilitate acceptance meetings.
• Manage and evaluate international regulatory projects in alignment with company goals. Support continuous enhancement of regulatory procedures and documentation practices.
• Strong knowledge of US, EU, and ICH regulatory guidelines.
• Experience in DMF and CEP compilation, amendments, and annual report filings. Detail-oriented with strong documentation and organizational abilities.
• Ability to handle multiple regulatory submissions while ensuring accuracy and compliance.