Regulatory Affairs Specialist

Key Accountabilities :

• Compile, format, and review scientific and technical data to prepare regulatory dossiers (e.g., CTD modules) for new products, variations, and renewals.
• Prepare and submit registration files to the EDA and handle responses to agency deficiencies.
• Prepare and manage documentation for international product registrations, including legal documents and responses to queries from foreign agents/authorities.
• Compile dossiers for veterinary products, ensuring inclusion of species-specific data, residue studies, and compliance with VICH guidelines.
• Maintain detailed and organized records of all regulatory submissions, correspondence, and approvals.
• Review product labeling, leaflets, and promotional materials for regulatory compliance.
• Cross functional collaboration with different departments like R&D , QC, QA And supply chain involved in all regulatory and technical submissions

Qualification:

• Bachelor’s degree in Pharmacy is a must
• 1-3 years of experience in regulatory affairs or a related field (e.g., QA, R&D).
• Experience with CTD format and electronic submission platforms is a strong advantage.