Senior Regulatory Affairs Associate

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

📋 Description

• Assist in the preparation, including relevant writing, and submission of straightforward and progressively complex regulatory maintenance filings from both global and/or regional perspectives.

• Write and evaluate CMC elements of Marketing Authorization Applications and Variations for medicinal products submitted in the EU.

• Create documentation for Super Grouping, Grouping, and Work-sharing variation processes.

• Assess DMFs, batch records, specifications, and stability data to ensure regulatory compliance.

• Draft CMC components for annual reports, renewals, GMP submissions, and site registrations.

• Provide regulatory impact evaluations for change controls and determine necessary documentation for EU/US and other market submissions.

• Collaborate closely with cross-functional team members who hold aligned product responsibilities.

• Implement and uphold submission delivery schedules and submission content plans.

• Actively provide status updates to designated stakeholders.

• Prepare, review, and submit safety variations to Health Authorities.

• Conduct post-approval CMC-related updates.

• Create label content for the EU, Canada, Australia/New Zealand, and the US based on CCDS, PRAC, and CMDH recommendations.

• Mentor and guide team members.

⛳️ Requirements

• Relevant experience in managing the life cycle of approved drug products, including small molecules and biologicals such as vaccines and monoclonal antibodies, across multiple markets.

• Strong understanding of regulatory frameworks and regional trends for different application types and procedures.

• Proficient knowledge of EU/US regulatory processes, including post-approval obligations.

• Experience managing CMC-related inquiries from health authorities and drafting responses.

• Awareness of global pharmaceutical regulations and ICH regulatory CMC guidelines.

• Proven experience in authoring and reviewing CMC elements of Marketing Authorization Applications and Variations for both oral and parenteral medicinal products.

• Familiarity with EU DCP, MRP, and National Procedures.

• Experience in preparing documentation for Super Grouping, Grouping, and Work-sharing variations.

• Background in reviewing DMFs, batch records, specifications, and stability data for regulatory compliance.

• Competence in authoring CMC components of annual reports, renewals, GMP submissions, and site registrations.

• Experience in providing regulatory impact assessments for change controls and identifying documentation needs.

• Proficient with Regulatory Information Management Systems such as Veeva Vault.

• Excellent communication skills with the ability to mentor and guide team members.

• Capability to work independently.

• Familiarity with EU Guidelines for QRD and Excipients.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and continuous learning.

• Collaborative and innovative work environment.

• Flexible working hours and remote work options.