Manage Regulatory Intelligence (legislation and
guidelines within the pharmaceutical/healthcare industry) and local regulatory
plans. Ensure regulatory approvals, license to operate aligned with local
business demands.
Ensure maintenance of RA IT systems
Influence and Monitor local regulatory environment and ensure compliance
Provide regulatory support and insight to external and internal stakeholders
Develop
Affiliate level regulatory strategy and Implementation Plans (IPs)
Develop local RA teams
Manage the local Quality Assurances and related team
Representation of India in global platform like AAMEO, IO and HQ
· Overall minimum of 10 years’ experience with a minimum of 5 years relevant experience required
Post Graduate in Pharmaceutical, medical science or related field or relevant business orientation· Advanced degree preferred (PhD, MBA, MDs, MS)
· Advanced knowledge of pertinent local regulations required
· Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred