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
- 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.
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.