Key Priorities & Challenges
- Guardians of the development, implementation of the effective programs to monitor / manage Regulatory shifts across Malaysia & Brunei.
- Work with Group / Local Legal to Manage risk and ensure all new regulatory shifts that relate to Non-Food are managed effectively to ensure seamless transition.
- Lead the communication of all Regulatory Product / Supplier alerts (e.g. Withdrawal / Recall) in countries.
- Develop and implement the appropriate control mechanisms to manage all local importations / indents products and labelling requirements
- Main point of contact for all escalated Regulatory Challenges and liaison local authority
- Main point of contact for ISO13485 & GDPMD management system, leads internal audits & external audits and all activities in maintaining the certification.
- In charge of all Own Brand & Indent product registration in Malaysia & Brunei (Cosmetics, Medical Devices, health Supplements, Drugs)
Key Responsibilities
- Provide expertise and guidance on health & beauty regulatory affairs to Group RA, Product Technology, Sourcing, Marketing, Operations, Supply Chain, and Commercial with regulatory guidance in order to ensure all Government legislation are met.
- Maintain local relationship with government to keep active track of potential changes in product regulations, liaise with government contacts for day to day interpretation of various regulations and guidelines
- Monitoring the regulation trend on the markets and updating the internal stakeholder, and conduct risk assessments/analyses and anticipates possible business impacts.
- Proactively provides regulatory related coaching on merchandising process execution and compliance trainings to internal stakeholders.
- Monitoring all markets product license validity and provide sufficient support and guidance for all the product registration in all markets.
- Provide Group RA with local countries regulatory advice on product claim, market materials and relevant programs to ensure full regulatory compliance.
- Support local operation & product technology teams for product complaint investigation & remedial executions at local banner level.
Key Requirement
Education:
Required: Bachelor&aposs Degree in Pharmaceutical, Chemistry, Chemical Engineering or related sciences.
Experience:
Required: Minimum of 8 years experience in in regulatory affairs for Non-Food (Health & Beauty and other regulated non-food products) Development / Manufacturing. Solid experience in product registration for Cosmetic, Medical Device, Health Supplements, Drugs in Malaysia / Brunei. Solid experience in leading ISO13485 / GDPMD quality system maintenance & certification audits.
Competencies:
- Proficient knowledge of health and beauty related legislation, policies and guidelines regarding product regulations requirements
- Lead the team to handle product registration/notification process for own brand products with regulatory authorities
- Strong knowledge in impending government policies and initiatives with creative regulatory problem solving
- Demonstrated ability to work independently, communicate effectively, work under pressure, and prioritize tasks effectively to meet deadlines
- Excellent organizational and prioritization skills with the ability to manage multiple projects with demonstrated flexibility and adaptability
- Demonstrated problem solving, decision making, and negotiating skills
- Excellent oral and written communication skills in both English
- Excellent interpersonal skills and be a team player
- Proficiency with Microsoft office (all aspects)
