About Company:
Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Backed by 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, generics, biosimilars, custom pharmaceutical services and branded generics. The company is globally recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products. Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, approved by stringent global regulatory authorities. Our portfolio includes 300 plus products encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology, Urology, Diabetes, Ophthalmology, Hepatology and Immunology etc. Hetero has a strong global presence in over 145+ countries and focusses on making affordable medicines accessible to patients worldwide.
Website
http://www.hetero.com
Vacancy Details:
Job Description:
We’re Hiring!
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 ICF guidelines. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports.
KEY RESPONSIBILITIES:
1.Prepare and submit regulatory dossiers for emerging and global markets, including Brazil, China, LATAM, US, EU, and ICH regions.
2.Stay updated with evolving regulatory requirements and implement changes in documentation
3.Handle regulatory filings, including annual updates and amendments.
4.Participate in deficiency meetings, review pending deficiencies, and collaborate with cross-functional teams to ensure timely submission of responses.
5.Review documents, identify gaps, ensure compliance, and facilitate acceptance meetings.
6.Manage and evaluate international regulatory projects in alignment with company goals.
7.Support continuous enhancement of regulatory procedures and documentation practices.
8.Strong knowledge of US, EU, and ICH regulatory guidelines.
9.Experience in DMF and CEP compilation, amendments, and annual report filings.
10.Detail-oriented with strong documentation and organizational abilities.
11.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
o www.hetero.com
