Regulatory Affairs Specialist

About the role

We are looking for a Regulatory Affairs Specialist to support regulatory submissions, compliance activities, and strategy throughout the product lifecycle. The role works closely with cross‑functional teams to ensure our products meet all applicable regulatory requirements and achieve successful market access.

Key responsibilities

• Prepare, review, and maintain regulatory documentation and submissions.
• Coordinate approval processes with authorities and internal stakeholders.
• Monitor regulatory changes, guidelines, and industry requirements.
• Support product registrations, renewals, variations, and lifecycle management.
• Review technical documents, labels, packaging, and promotional content for compliance.
• Collaborate with quality, R&D, manufacturing, marketing, and supply‑chain teams.
• Maintain regulatory databases, records, and compliance documentation.
• Assist with regulatory audits, inspections, and authority communications.
• Provide regulatory guidance to internal teams and prepare status reports.

Required profile

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or related field.
• 2–5+ years of experience in regulatory affairs, quality assurance, compliance, or related roles.
• Strong understanding of regulatory processes, documentation requirements, and compliance standards.
• Excellent attention to detail, analytical, organizational, and problem‑solving abilities.
• Effective written and verbal communication skills.
• Ability to work collaboratively across functions and manage projects to meet deadlines.

Required skills

• Microsoft Office
• Regulatory information management systems