Formulation Regulatory Affairs Executive/ Assistant Manager

Hetero; Hyderabad; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Hetero in Hyderabad, India, is seeking a Regulatory Affairs professional to manage dossier preparation and submissions.

You will ensure compliance with CTD/ACTD guidelines, perform gap analyses, and respond to MOH queries, supporting lifecycle management.

The role involves coordinating documentation, renewals, and post-approval variations, with emphasis on EAEU/ICH/EMEA guidelines.

Qualifications

• Knowledge of regulatory guidelines for finished product registration.
• Experience compiling and reviewing product dossiers for CTD/ACTD.
• Ability to perform dossier gap analysis and address MOH gaps.
• Experience handling MOH queries and lifecycle management.
• Familiarity with EAEU, ICH and EMEA guidelines.
• Experience with post-approval variations and renewals.
• Knowledge of COPP, manufacturing and import licenses.
• Experience updating registration information management systems.

Responsibilities

• Compile and review product dossiers for CTD/ACTD submissions.
• Perform dossier gap analysis and address MOH gaps before submission.
• Handle MOH queries and communicate with customers.
• Manage lifecycle of products and post-approval variations.
• Prepare development reports, scale-up reports, specifications, COA, stability and PV protocols.
• Review documents (specifications, STP, analytical method validations, development and validation reports, BMR/BPR).
• Maintain documentation for COPP, licenses and regulatory filings.
• Keep Registration Information Management System updated.

Skills

Regulatory guidelines

Dossier compilation

CTD/ACTD submissions

MOH queries handling

Lifecycle management

Regulatory knowledge (EAEU, ICH, EMEA)

Post-approval variations

Document review

Tools

Registration information management system

Job description

Role & responsibilities

• Keen Knowledge on Regulatory guidelines for finished product registration.
• Dossier compilation as per guidelines.
• Compilation and review the product dossiers for submission in CTD, ACTD.
• Gap analysis of the dossier and addressing the gaps before submission to MOH.
• Handling the customer and MOH queries.
• Life cycle management of the product.
• Development report, scale up report, specification, COA, stability protocol and Process validation protocol.
• Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability).
• Post approval experience to file the applicable variations timely.
• Knowledge on EAEU, ICH and EMEA guidelines.
• Re-registration (Renewal) procedures.
• Administrative documents requirements (COPP, Mfg. License and Import License) .
• Registration information management system updates on regular basis.