Regulatory Affairs Executive

Ensure efficient and effective regulatory affairs support to assist the Regulatory Affairs team in ensuring that products and processes comply with all relevant regulations, guidelines, and standards throughout the product lifecycle in the applicable markets.

Core Responsibilities

• Compile and submit complete registration dossiers for product notification, registration, and approvals, including licenses, permits, and certifications.
• Assist the Regulatory Affairs team in the timely submission of regulatory documents to secure approvals in alignment with business timelines and provide status updates.
• Support the review of formulations, product specifications, artwork, promotional materials, and advertisements to ensure compliance.
• Assist with regulatory assessments, claims support documentation, and literature searches.
• Collaborate with the Regulatory Operations team in compiling product information files.
• Maintain and update regulatory files, records, and databases related to submissions to support efficient regulatory operations.
• Provide support during external audits by regulatory authorities, including post-market surveillance and certification audits.
• Contribute to the development and updating of standard operating procedures (SOPs), guidelines, and internal regulatory documents.
• Assist in developing and delivering regulatory and compliance training materials.
• Participate in cross-functional meetings to support effective regulatory operations.
• Monitor changes in regulatory requirements and conduct research on relevant regulations.
• Provide administrative support for regulatory activities, including purchase orders and other operational tasks.
• Perform additional duties as assigned by the immediate manager or regional regulatory lead.

Education Requirements

• Minimum of a Bachelor's degree in Pharmacy or a related field from a recognized university.

Experience Requirements

• 2–5 years of experience in regulatory affairs within the cosmetics, consumer goods, or pharmaceutical industries.
• Experience with certification processes (e.g., Halal certification) is an advantage.

Competencies & Skills Required

• Strong understanding of regulatory affairs principles, regulations, and guidelines for cosmetic and medical device products.
• Knowledge of pharmaceutical product regulations is an advantage.
• Familiarity with the product development process and regulatory requirements at each stage.
• Strong written and verbal communication skills with good interpersonal abilities.
• Effective planning and organizational skills, with the ability to prioritize and manage multiple projects.
• Strong analytical skills and attention to detail.
• Proficiency in computer applications, including regulatory databases, Adobe Acrobat, Google Suite, and online regulatory portals.
• Fluency in spoken and written English.
• Adaptability and ability to work in a dynamic regulatory environment.

Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.