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Hetero Biopharma, established in 2009, is the biopharmaceutical division of the Hetero Group, a prominent pharmaceutical company headquartered in Hyderabad, India. Specializing in the development and manufacturing of biosimilars, monoclonal antibodies (mAbs), recombinant proteins, vaccines, cell and gene therapies, and small molecule products, Hetero Biopharma is committed to making complex biologics affordable and accessible worldwide.
Requirement Details:
Department: Regulatory Affairs – API
Experience
: 2-8 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 IC 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.
How to apply ?
Interested Candidates can share your Cv’s to prathap.p@hetero.com
