Regulatory Executive Job Hetero – Apply Now!
Join Hetero, a global pharmaceutical leader, as an Executive in Regulatory Affairs. Play a key role in Drug Master File (DMF) and Certificate of Suitability (CEP) submissions, ensuring compliance with international regulatory guidelines. If you have 2-5 years of experience in API Regulatory Affairs and a background in Organic Chemistry or Pharmaceuticals, apply today!
About the Company
Hetero is a leading pharmaceutical company dedicated to the development, manufacturing, and marketing of high-quality generic pharmaceutical products globally. With a strong commitment to compliance and innovation, Hetero is at the forefront of providing affordable healthcare solutions.
Summary: The ideal candidate will be responsible for compiling Drug Master Files (DMFs) and Certificates of Suitability (CEPs), ensuring compliance with country-specific and global regulatory guidelines. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports.
Job Posting: Regulatory Executive Position
Experience: 2-5 years of experience in Regulatory Affairs within the API industry.
Qualification: M.SC (Organic Chemistry) / M. PHARMA (Pharmaceuticals) / B. PHARMA (Pharmaceuticals)
Key Responsibilities of Regulatory Executive Job Hetero:
- 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.
- Excellent communication and coordination skills.
- Detail-oriented with strong documentation and organizational abilities.
- Ability to handle multiple regulatory submissions while ensuring accuracy and compliance.
Keywords: Executive Position, Regulatory Affairs, Compliance, Pharmaceutical Industry, Hetero, Global Markets
