Fluent in EnglishImmediate JoinerExperience: Minimum 3 yearsThe Regulatory Representative is responsible for ensuring compliance with all relevant regulations and standards in the development, manufacturing, and marketing of the company's products. This role involves preparing and submitting documentation for regulatory approvals, monitoring regulatory changes, and advising the company on regulatory strategies and requirements.Key Responsibilities:\xc2\xb7 Prepare and submit regulatory documents to relevant authorities (e.g., FDA, EMA) for product approvals, renewals, and variations.\xc2\xb7 Ensure all submissions comply with applicable regulations and guidelines.\xc2\xb7 Monitor and interpret regulatory requirements and ensure company compliance.\xc2\xb7 Maintain knowledge of current and future regulations, guidelines, and standards.\xc2\xb7 Conduct internal audits and assessments to ensure ongoing compliance.\xc2\xb7 Maintain and update regulatory documentation, including technical files, product labels, and marketing materials.\xc2\xb7 Generate and review reports, regulatory dossiers, and other documentation as required.\xc2\xb7 Work closely with other departments, including R&D, Quality Assurance, Manufacturing, and Marketing, to provide regulatory guidance and support.\xc2\xb7 Participate in project teams to ensure regulatory requirements are integrated into product development plans.\xc2\xb7 Develop and implement regulatory strategies to facilitate product development and approval processes.\xc2\xb7 Advise on regulatory aspects of new product development and market entry.\xc2\xb7 Provide training to company staff on regulatory requirements and best practices.\xc2\xb7 Stay updated on industry trends and developments and disseminate relevant information within the organization.\xc2\xb7 Liaise with regulatory authorities and external consultants to ensure timely resolution of regulatory issues.\xc2\xb7 Represent the company at regulatory meetings, industry conferences, and seminars.Job Types: Full-time, PermanentPay: \xe2\x82\xb950,000.00 - \xe2\x82\xb960,000.00 per monthBenefits:

• Provident Fund

Schedule:

• Day shift

Supplemental pay types:

• Yearly bonus

Experience:

• total work: 5 years (Preferred)

Work Location: In person