- Develop and implement regulatory strategies to ensure timely approval of pharmaceutical products in target markets.
- Prepare, review, and submit regulatory documents to health authorities in compliance with local and international regulations.
- Maintain up-to-date knowledge of relevant regulatory requirements, guidelines, and industry trends affecting pharmaceutical products.
- Liaise with cross-functional teams including R&D, quality assurance, manufacturing, and marketing to ensure regulatory compliance throughout the product lifecycle.
- Serve as the primary contact with regulatory agencies, responding to queries and providing necessary documentation.
- Monitor and manage regulatory submissions, approvals, renewals, and post-approval changes.
- Assess and communicate regulatory risks and opportunities to senior management and project teams.
- Ensure all product labeling, packaging, and promotional materials comply with applicable regulations.
- Lead and mentor junior regulatory staff, fostering a culture of compliance and continuous improvement.
- Support audits and inspections by regulatory authorities, ensuring readiness and timely resolution of findings.
Minimum of 3 years and up to 6 years of experience in regulatory affairs within the Cosmeceutical industry.Proven track record of successful regulatory submissions and approvals for pharmaceutical products.Strong understanding of global regulatory frameworks, including FDA, EMA, NFSA and other relevant authorities.Excellent project management and organizational skills with the ability to manage multiple priorities.Demonstrated leadership and team management capabilities at a mid-level career stage.Exceptional written and verbal communication skills for effective interaction with regulatory agencies and internal stakeholders.Detail-oriented with a high level of accuracy in preparing and reviewing regulatory documents.Ability to analyze complex regulatory information and provide clear guidance to cross-functional teams.Experience working in an onsite (office-based) environment.Familiarity with electronic submission systems and regulatory databases.