Regulatory Affairs Associate

About the Role

We are seeking a Regulatory Affairs Associate to support the submission and lifecycle management of pharmaceutical products for a mid-sized speciality pharma company. You will work closely with R&D, manufacturing, and legal teams to prepare and submit accurate regulatory dossiers. This role is ideal for a detail-oriented professional who is passionate about ensuring that safe, effective medicines reach patients.

Key Responsibilities

• Compile, review, and submit regulatory dossiers (CTD/eCTD format) to global health authorities.
• Ensure all regulatory submissions are accurate, complete, and meet compliance standards.
• Liaise with regulatory agencies (e.g., CDSCO, USFDA, EMA) regarding product registrations.
• Review labelling and promotional materials for regulatory compliance.
• Stay updated on changing regulations and advise internal teams on impact.

Requirements & Experience

• 2-4 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Degree in Pharmacy (B.Pharm/M.Pharm) or Life Sciences.
• Solid understanding of national and international regulatory guidelines.
• Experience with eCTD preparation and submission processes.
• Strong organisational skills and attention to detail.