Deputy Manager, Regulatory Affairs

8-10 Years

Save

Early Applicant

Job Description

Key Responsibilities

JOB DESCRIPTION

Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance, and Manufacturing teams.
Ensure dossier compliance with WHO, ICH, and local authority guidelines.
Regulatory Strategy & Market Support
Develop registration strategies for RoW markets considering country‑specific regulations.
Support business development by providing regulatory feasibility and timelines for new markets/products.
Assess regulatory impact for formulation/site changes.
Regulatory Lifecycle Management
Manage post‑approval changes, including:

Track and ensure timely renewals/re‑registrations.
Maintain approved product documentation and regulatory databases.
Health Authority Interaction
Handle deficiency letters / queries from regulatory agencies.
Prepare responses in coordination with internal stakeholders.
Liaise with local agents, consultants, and partners for RoW countries.
Compliance & Intelligence
Monitor regulatory guideline updates for RoW markets.
Ensure submissions comply with the latest country requirements.
Support internal audits, regulatory inspections, and due‑diligence audits.
Team & Project Coordination
Mentor junior team members and review their regulatory work.
Track regulatory milestones and ensure alignment with project timelines.
Participate in cross‑functional meetings for project planning and risk assessment.