Executive / Senior Executive

Role & responsibilities

• Prepare, review, and submit regulatory dossiers for product approvals, renewals, and variations in compliance with local and international regulations.
• Ensure all regulatory submissions are complete, accurate, and timely in alignment with organizational objectives.
• Maintain updated knowledge of regulatory requirements, guidelines, and changes across domestic and international markets.
• Coordinate with R&D, QA/QC, production, and marketing teams to gather technical data required for submissions.
• Manage regulatory databases, track approval timelines, and ensure documents are archived systematically.
• Respond to queries from regulatory authorities and provide clarification in coordination with technical teams.
• Monitor product labeling, safety data sheets, and packaging for regulatory compliance.
• Support audits, inspections, and due diligence exercises with regulatory authorities or clients.

Provide training and guidance to internal teams on regulatory requirements and updates.

Preferred candidate profile

• Strong knowledge of regulatory guidelines (CIBRC, REACH, EPA, EU, OECD, BIS, etc.).
• Excellent documentation, data management, and analytical skills.
• Strong communication skills to coordinate with internal teams and external authorities.
• Proactive, detail-oriented, and capable of managing multiple submissions simultaneously.
• Ability to work independently as well as part of a team in a fast-paced environment.
• Prior experience in dossier preparation, product registration, and regulatory submissions is essential.