Regulatory Affairs Lead

We are seeking a detail-oriented Regulatory Affairs Specialist to support regulatory compliance and product approvals across domestic and international markets. The ideal candidate will be responsible for preparing and maintaining regulatory submissions, ensuring compliance with applicable regulations, and collaborating with cross-functional teams to support product development, manufacturing, and commercialization.

• Prepare, review, and submit regulatory documentation to support product registrations, approvals, and renewals.
• Monitor changes in regulatory requirements and assess their impact on products and business operations.
• Ensure products and processes comply with applicable local, national, and international regulations.
• Collaborate with Quality, R&D, Manufacturing, Clinical, and Commercial teams throughout the product lifecycle.
• Maintain regulatory files, technical documentation, and product records.
• Support responses to regulatory agency inquiries, audits, inspections, and compliance reviews.
• Assist with product labeling, claims review, and documentation updates to ensure regulatory compliance.
• Coordinate regulatory activities for new product launches, product modifications, and market expansions.
• Identify regulatory risks and recommend appropriate mitigation strategies.
• Contribute to continuous improvement of regulatory processes and documentation practices.

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Biomedical Engineering, Engineering, or a related field.
• 3-7 years of experience in Regulatory Affairs or Regulatory Compliance.
• Strong understanding of regulatory requirements and product registration processes.
• Experience preparing and managing regulatory submissions and technical documentation.
• Knowledge of quality systems and applicable regulatory standards.
• Excellent organizational, analytical, and documentation skills.
• Strong communication and stakeholder management abilities.
• Ability to manage multiple projects and meet regulatory deadlines.

• Experience working with regulated industries such as Medical Devices, Pharmaceuticals, Biotechnology, Diagnostics, Consumer Healthcare, or Food & Beverage.
• Familiarity with regulatory agencies such as FDA, EMA, MHRA, Health Canada, or other global regulatory authorities.
• Knowledge of standards and regulations such as ISO 13485, GMP, GLP, MDR, IVDR, or 21 CFR, depending on the industry.
• RAC (Regulatory Affairs Certification) or other relevant certifications are a plus.