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Regulatory Affairs Consultant – Local Regulatory Affairs Operations
Location
India
Posted
10 days ago
Salary
0
Seniority
Lead
Job Description
Regulatory Affairs Consultant – Local Regulatory Affairs Operations
Parexel
• Managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. • Partnering with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.
Job Requirements
- 7+ years' experience in supporting regulatory submissions including MAAs (Marketing Authorization Application)
- Europe working knowledge on EU procedures including centralized procedures coordination and management.
- Preparation and coordination for Module 1 activities for CMC, Safety, Administrative, MA transfer’s, Article 31 & other post approval variations & MAA’s.
- Assist with DHCP (Direct Healthcare Professional Communication) related activities and commitments follow-up
- Manage submissions through local Health Authority portals as required
- Handle post-approval lifecycle management activities and regulatory communication-RIMS (Regulatory Information Management Systems)-VEEVA Vault
- Support linguistic review processes including translation review and coordination
- Conduct readability testing and support artwork (AW) review, mock-ups, and approvals
- Support promotional material review including Abbreviated Product Information (API) creation or updates and Regulatory Affairs review processes (including UK pre-vetting)
- Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level.
- Collaborate with global, regional, and affiliate stakeholders on launches, audits, inspections, change controls, deviations, and market updates
Benefits
- Flexible working arrangements
- Professional development opportunities
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