Regulatory Affairs Manager

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).

• Education: Bachelor’s degree or higher in Law, Pharmacy, Chemistry, Biotechnology, Food Science, Life Sciences, or a related field.
• Experience: Minimum of 5–7 years of experience in Regulatory Affairs, with at least 2–3 years in a managerial or supervisory role (Experience in FMCG, Healthcare, Pharmaceuticals, or Nutrition industries is highly preferred).

Technical Skills:

• Deep understanding of local regulatory frameworks (e.g., Ministry of Health, Ministry of Industry and Trade, or relevant regional authorities).
• Proven track record of successful product registrations and navigating complex compliance challenges.

Soft Skills:

• Strong leadership, people management, and team-building capabilities.
• Excellent negotiation, interpersonal, and stakeholder management skills.
• Analytical mindset with meticulous attention to detail and sharp problem-solving abilities.
• Language: Fluency in English (both written and spoken) is required for processing international documentation and reporting.