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Regulatory Affairs Consultant – Local Regulatory Affairs Operations

ComplianceComplianceFull TimeRemoteLeadTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

India

Posted

10 days ago

Salary

0

Seniority

Lead

Postgraduate Degree7 yrs expEnglishVault

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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