Regulatory Affairs Specialist / Associate

Location: Hyderabad (India)

Employment Type: Full-time

Role summary

We are seeking an experienced Regulatory Affairs Professional to support regulatory submissions, compliance, and product lifecycle management. The ideal candidate will have strong expertise in drug/medical device regulations, dossier preparation, and global regulatory guidelines, ensuring timely approvals and compliance for new and existing products.

Key Responsibilities

•Prepare, review, and submit regulatory dossiers (CTD/eCTD) to global health authorities (US FDA, EMA, MHRA, DCGI, etc.)
•Support IND, NDA, ANDA, DMF, MAAs and post-approval regulatory activities
•Maintain up-to-date knowledge of regulatory requirements and guidelines across markets
•Liaise with R&D, QA, QC, Manufacturing, and Clinical teams to ensure regulatory compliance
•Manage product registrations, renewals, and variations in multiple regions
•Review labeling, promotional, and packaging content to ensure regulatory compliance
•Track and respond to regulatory queries and deficiency letters from authorities
•Ensure timely communication of regulatory changes and risks to stakeholders
•For senior positions: mentor junior regulatory staff and contribute to strategy development

Skills & Qualifications

•Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or related fields
•Strong knowledge of drug regulations, CTD/eCTD submissions, and global regulatory guidelines
•Experience in dossier preparation, publishing tools, and regulatory databases
•Familiarity with medical devices and combination products is a plus
•Excellent documentation, communication, and cross-functional collaboration skills
•Ability to handle multiple projects and meet submission timelines

Experience

Regulatory Affairs Specialist: 3–6 years of experience in regulatory submissions & compliance

Senior/Associate Manager: 7–12 years with proven expertise in global regulatory strategy & submissions