Executive, Regulatory Affairs

Job Responsibilities

• Implement strategies for regulatory approval and ensuring compliance with regional and international regulations for all product categories of the company.
• Develop a comprehensive understanding and maintain current knowledge of the regional and international regulations and standards applicable to the company products.
• Co-ordinate, prepare, submit and follow up registration applications to regional authorities within the stipulated timeline, and to high standards, to ensure that market permissions are obtained and maintained in line with the company’s plans.
• Liaise with suppliers/contract manufacturers for documents required for product registration and other related regulatory matters.
• Ensure timely registration or license renewal of products and that submissions meet strict deadlines.
• Maintain and update requirements for labelling and consolidated standards of regulatory safety limits applicable to the company products.
• Review labelling, summary of product characteristics and marketing material to ensure compliance with current legislation and registered particulars and take action.
• Maintain and implement the product artwork and label management system.
• Maintain an internal finished product and ingredient database.
• Keep up to date with changes in regulatory legislation, guidelines and best practices, provide updates and assess the impact of these changes on the products or the company.
• Implement and update standard procedures for, monitor and ensure timely completion of reactions to regulatory requirement changes.
• Foster collaborative, efficient and effective working relations, liaise and negotiate with regulatory authorities such as the HSA, SFA, regulatory agencies and industrial associations.
• Give regulatory advice, develop and maintain links to other teams (including product, quality, supply chain, logistics, marketing, design) so that appropriate development, quality or marketing plans may be established.
• Ensure best practice for filing/ archiving of relevant product correspondence; create and update Product Information Files to high standards.

Requirements

• Degree in science, preferably in chemistry, biochemistry, pharmacy, biomedical science, cosmetic science or similar
• Proven relevant experience within the regulatory environment
• Proven familiarity and experience in the cosmetic, health food, dietary supplement, pharmaceuticalor other FMCG industry
• Experience in ASEAN TMHS and/or cosmetic regulations, including PIF handling, is preferred
• Self-starter, good at working well independently with initiatives
• Meticulous & detail-oriented
• Planning & organising skills; time management skills
• Communication & negotiation skills
• Analytical & problem-solving skills