ROLE
– Manage regulatory affairs activities and regulatory strategy execution
– Oversee preparation, review, and submission of regulatory dossiers, technical documentation, and product registration applications
– Monitor regulatory developments, policy updates, and industry intelligence
– Coordinate regulatory communications, responses, and compliance documentation for interactions with health authorities
– Collaborate with cross-functional teams to strengthen regulatory governance, documentation control, and compliance monitoring
– Lead and review dossier compilation & publishing for complex submissions
– Oversee DMF compilation & review process and submission strategies
– Direct eCTD & electronic submissions across regions
– Manage post-submission management and health authority responses
– Ensure robust document version control & governance
– Monitor regulatory intelligence and assess strategic impact
– Drive regulatory & supplement reporting and lifecycle updates
– Coordinate regulatory & health authority management engagements
– Ensure inspection readiness for DMF and audit preparedness
– Apply risk identification & mitigation in regulatory planning
– Ensure sustained regulatory compliance across product lifecycle
– Lead quality & audit readiness initiatives

BENEFITS
– No benefits mentioned in the job description