We are seeking a motivated Regulatory Affairs Associate to support regulatory submissions and ensure compliance with applicable regulatory requirements. The ideal candidate will assist in preparing documentation, coordinating with internal teams, and maintaining regulatory records.
Key ResponsibilitiesAssist in preparing and submitting regulatory documents to health authorities.
Support preparation of regulatory submissions such as CTD/eCTD, dossiers, variations, and renewals .
Review product labels, packaging materials, and promotional content to ensure regulatory compliance.
Maintain regulatory documentation and databases.
Track regulatory submission timelines and approvals.
Coordinate with R&D, Quality Assurance, Manufacturing, and Marketing teams for regulatory requirements.
Monitor regulatory updates and ensure compliance with applicable guidelines.
Assist in responding to regulatory authority queries.
Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
0 2 years of experience in Regulatory Affairs (freshers with relevant internships can apply).
Basic understanding of regulatory guidelines (FDA, EMA, CDSCO, or other relevant authorities).
Good documentation and communication skills.
Attention to detail and ability to work with regulatory documentation.
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