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Hetero Drugs – Regulatory Affairs Job Vacancies

Hetero Drugs – Regulatory Affairs Job Vacancies

Hetero Drugs, a leading Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs, is currently seeking candidates for Regulatory Affairs positions. Hetero’s diverse business portfolio includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. With a strong focus on research and development (R&D), manufacturing, and marketing, Hetero Drugs is globally renowned for its high-quality chemical and biologic medicines across various therapeutic areas.

Position: Regulatory Affairs

Experience: 2 to 8 Years

Markets: RO, EU, US

Qualification: B.Pharma / M.Pharm

Job Description:

  • Thorough knowledge of regulatory guidelines for finished product registration.
  • Compilation and review of product dossiers for submission in CTD (Common Technical Document) and ACTD (ASEAN Common Technical Document).
  • Conducting gap analysis of the dossier and addressing any gaps prior to submission to the Ministry of Health (MOH).
  • Handling customer and MOH queries.
  • Life cycle management of the product.
  • Compilation and submission of ANDA’s (Abbreviated New Drug Applications) and EU dossiers.
  • Experience in filing applicable variations in a timely manner, both pre- and post-approval.
  • Familiarity with EU, ICH, and EMEA guidelines.

Work Location: Jedimetla Unit VII, Hyderabad

What to bring to the interview:

  • Academic documents, including certificates and mark sheets.
  • Pay slips and appointment letters from previous employers.
  • Details of current compensation (CTC) and identification proof.

Walk-in-Interview Details:

Date: 3rd June 2023 (Saturday)

Time: 9:00 a.m. to 3:00 p.m.

Venue: Hetero Labs Limited, Unit VII Plot No: 14, Jeedimetla, Qutubullapur(M), Medchal Dist., Hyderabad, Telangana

Note: Please make sure to bring all the required documents mentioned above for the interview. The walk-in interview will be held on the specified date and time at the provided venue.

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