Regulatory Affairs Consultant – Local Regulatory Affairs Operations

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee post-approval regulatory tasks, which encompass variations, renewals, and adherence to specific country requirements.

• Collaborate with cross-functional teams to ensure prompt submissions and upkeep of regulatory dossiers.

⛳️ Requirements

• A minimum of 7 years of experience in supporting regulatory submissions, including Marketing Authorization Applications (MAAs), variations (both minor and major), responses to inquiries, renewals, withdrawals, and marketing authorization transfers.

• Proficient understanding of EU procedures, including the coordination and management of centralized procedures.

• Experience in preparing and coordinating Module 1 activities related to CMC, Safety, Administrative tasks, MA transfers, Article 31, and other post-approval variations and MAAs.

• Provide assistance with Direct Healthcare Professional Communication (DHCP) activities and follow up on commitments.

• Manage submissions through local Health Authority portals as necessary.

• Oversee post-approval lifecycle management activities and regulatory communications using Regulatory Information Management Systems (RIMS) and VEEVA Vault.

• Support linguistic review processes, including translation reviews and coordination.

• Conduct readability tests and assist with artwork reviews, mock-ups, and approvals.

• Aid in the review of promotional materials, including the creation or updates of Abbreviated Product Information (API) and the regulatory affairs review processes, including UK pre-vetting.

• Contribute to Periodic Safety Update Report (PSUR) submissions and engage in regulatory intelligence activities at the country level.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and further training.

• Flexible working hours and a supportive work environment.