Tuesday, April 12, 2022

Hetero labs Limited Urgent Openings for Regulatory Affairs – Formulation / API

 Hetero Labs Limited is one of India’s generic pharmaceutical companies and the “world’s largest producer of anti-retroviral drugs”. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. HETERO is one of the India’s leading generic pharmaceutical companies and is one of the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world. The company is recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products.



  • Department: Regulatory Affairs
  • Industry: Pharma Only
  • Experience: 3 to 8 years
  • Qualification: B.Pharm/M.Pharm/M.Sc
  • Salary: As Per Industry Norms
  • Location: Hyderabad

Roles and Responsibilities

  • Preparation and review of Dossiers as per the current prescribe ICH guidelines for the
  • ASEAN, African, CIS, Europe & Latin American Countries, Brazil, UAE

The List of Countries are mention below-

  1. ASEAN- Malaysia, Vietnam, Philippines, Myanmar and Cambodia.
  2. Africa- Tanzania, Uganda, Ethiopia, Kenya, Rwanda, Ivory coast, Cameroon, Burkina
  3. Faso, Benin, Togo, Mali, Chad, Madagascar, Gabon, Senegal, Guinee, Niger and Congo.
  4. CIS- Ukraine, Uzbekistan, Moldova, Kazakhstan, Kyrgyzstan, Tajikistan, Armenia,
  5. Azerbaijan, Georgia and Belarus.
  6. Europe- Portugal, Malta, Italy, Austria, Germany.
  7. Latin America-Bolivia, Dominique Republic, Haiti


Job Description:

  • Provided Regulatory guidance and expedite response to regulatory authorities and Ensured documentation complies with regulatory agencies.
  • Filling the post approval variation of Type IA, Type IB & Type II, and Grouping of Variations.
  • Review of Quality and analytical data as per the pharmacopeia, specification, MOA, STP, Annual product report, Change control documents, Batch Record, Stability, Finish products/ Packing material data for the purpose of compilation of the dossier.
  • Review of documents required for regulatory agencies (Viz , Analytical report, Process validation Protocol, process validation Report, Pharmaceutical development report, Protocols & stability data)
  • Preparation of various Pharmacological, Preclinical & Toxicological data based on published literature.
  • Preparation and review of labeling & packing materials and packing inserts of Finish formulation.
  • Preparation and review of SPC, packing insert and labeling information.

Desired Candidate Please Share Your Profile vivek.s@heterodrugs.com