Role Summary: Responsible for managing postapproval regulatory activities for the Europe market, ensuring timely submissions, compliance with EMEA requirements, and uninterrupted product lifecycle management.

Key Responsibilities:

- Prepare, review, and submit postapproval supplements (Type 1A, Type 1B, Type II) to European Authorities

- Prepare and submit responses to deficiency letters within timelines

- Review and approve change controls, ensuring correct regulatory classification and filing strategy

- Ensure completeness, accuracy, and compliance of all submission documents (CMC, labeling, stability)

- Track RLD labeling updates and ensure timely submission of labeling variations

- Monitor Ph.Eur. monograph updates and ensure regulatory compliance

- Evaluate vendor change notifications (API/excipients) and assess regulatory impact

- Maintain submission trackers and ensure adherence to regulatory timelines and commitments

- Coordinate with crossfunctional teams (R&D;, QA, QC, SCM, MSAT,



Operations) for seamless execution

Key Requirements:

- Strong experience in Europe Regulatory Affairs LCM

- Handson experience with Type 1A, Type 1B, Type II, and deficiency responses submissions

- Positive knowledge of Europe regulations (postapproval changes)

- Strong understanding of CMC, labeling, and stability requirements

- Ability to manage multiple submissions with tight timelines

Preferred Candidate Profile:

- Proven experience in managing commercial products lifecycle

- Strong attention to detail and regulatory compliance mindset

- Good communication and crossfunctional coordination skills

Objective: To ensure timely, compliant, and efficient lifecycle management of approved products for the Europe market, supporting business continuity and regulatory excellence.

📌 Executive/ Sr. Executive - Regulatory Affairs (Hyderabad)
🏢 Granules India
📍 Hyderabad