1. Regulatory Strategy & Compliance
- Develop and implement robust regulatory strategies to secure timely approval for new products and maintain existing product portfolios.
- Monitor, analyze, and interpret changes in local and international regulations, assessing their potential impact on business operations and product pipelines.
- Ensure all product formulas, labeling, packaging, and marketing claims strictly comply with relevant statutory guidelines and corporate policies.
2. Product Registration & Lifecycle Management
- Oversee the preparation, compilation, and submission of high-quality regulatory dossiers for new product registrations, renewals, and variations.
- Manage the lifecycle of product licenses and ensure timely renewals to prevent any disruption in supply chain or sales.
- Coordinate with R&D, Quality Assurance, and Supply Chain teams to ensure technical documentation meets regulatory standards.
3. Stakeholder Management & Government Relations
- Build and maintain strong, professional relationships with key regulatory bodies, government officials, and industry associations.
- Represent the company in external regulatory forums, public consultations, and industry working groups to advocate for favorable regulatory environments.
- Manage external consultants, scientific experts, and legal counsel when specialized regulatory support is required.
4. Team Leadership & Risk Management
- Lead, mentor, and develop the Regulatory Affairs team, fostering a culture of high performance, compliance, and continuous learning.
- Conduct proactive regulatory risk assessments and establish mitigation plans for product launches or formulation changes.
- Provide timely regulatory guidance and training to cross-functional teams (Marketing, Sales, Legal, and Supply Chain).
