Hetero is a leading global pharmaceutical company specializing in the manufacture of generic drugs and active pharmaceutical ingredients (APIs). With a strong presence in over 120+ countries, Hetero is known for its high-quality, affordable medicines. The company has a robust R&D and regulatory framework, ensuring compliance with international standards.
Job Description
Hetero Labs is hiring for the role of Formulation Regulatory Affairs Executive/Assistant Manager in Hyderabad. The ideal candidate will have 3-8 years of experience in regulatory affairs, with expertise in dossier compilation, post-approval variations, and lifecycle management of pharmaceutical products.
Key Responsibilities:
- Dossier Compilation & Submission: Prepare and review regulatory dossiers in CTD, ACTD formats for global submissions.
- Regulatory Compliance: Ensure adherence to ICH, EAEU, EMEA, and other regulatory guidelines.
- Gap Analysis: Identify and address gaps in dossiers before submission to Ministry of Health (MOH).
- Query Handling: Respond to MOH and customer queries efficiently.
- Lifecycle Management: Manage post-approval variations, renewals, and re-registrations.
- Document Review: Review specifications, STPs, analytical method validations, development reports, BMR, BPR, PVP/R, and stability data.
- Regulatory Updates: Maintain Registration Information Management System (RIMS) with the latest updates.
Required Skills & Qualifications:
- Experience: 3-8 years in regulatory affairs (formulations).
- Knowledge: Strong understanding of global regulatory guidelines (EAEU, ICH, EMEA, WHO).
- Dossier Expertise: Hands-on experience in CTD/ACTD compilation, gap analysis, and query resolution.
- Post-Approval Variations: Experience in filing variations and renewals.
- Attention to Detail: Strong analytical skills for document review and compliance checks.
How to Apply?
- Walk-in Interview:
- Date: 25 May 2024
- Time: 9:30 AM – 3:00 PM
- Venue: Hetero Labs Unit VII, Jeedimetla, Hyderabad.
