United States onlyPrenetics, a leading genomics-driven health sciences company, is revolutionizing prevention, early detection, and treatment. Our prevention arm, CircleDNA, uses whole exome sequencing to offer the world's most comprehensive consumer DNA test. Insighta, our $200 million joint venture with renowned scientist Prof. Dennis Lo, underscores our unwavering commitment to saving lives through pioneering multi-cancer early detection technologies. Insighta plans to introduce Presight for lung and liver cancers in 2025, and to expand with Presight One for 10+ cancers in 2027. Lastly, ACT Genomics, our treatment unit, is the first Asia-based company to achieve FDA clearance for comprehensive genomic profiling of solid tumors via ACTOnco. Each of Prenetics' units synergistically enhances our global impact on health, truly embodying our commitment to 'enhancing life through science’.
At Prenetics, we believe that prevention is the key to a healthier future. By combining our innovative genomics-driven technologies with our new venture into vitamins and supplements, we aim to empower individuals to take tailored, proactive steps towards maintaining their well-being and leading healthier lives.
As core personnel for regulatory affairs and quality assurance for our new venture and latest product launch, you will play a key role in building out and managing our quality systems, and heavily supporting our Product Development and Supply Chain departments with regulatory compliance.
This is a dynamic, hands-on position where the individual will work with a diverse, global manufacturing and supply chain network.
The responsibilities of the position include, but are not limited to, the following:
- Develop, implement, and maintain procedural compliance documents encompassing product safety, supplier qualification, handling of out-of-specification results, adverse events, and product release, ensuring adherence to regulatory standards.
- Establish and execute a robust document and change control system specifically tailored for dietary supplement specifications and Standard Operating Procedures (SOPs), ensuring accuracy, completeness, and compliance with relevant regulations.
- Oversee and ensure the safety and compliance of all finished dietary supplement products through rigorous quality assurance measures and adherence to regulatory requirements.
- Collaborate closely with contract manufacturers and third-party agencies to coordinate product certifications, ensuring timely and accurate submissions and certifications.
- Conduct comprehensive investigations and provide expert guidance on country-specific regulations to support the seamless introduction of new products into various markets, mitigating regulatory risks and ensuring compliance.
- Support the Research and Development (R&D) teams to develop comprehensive finished product specifications aligned with regulatory requirements and industry best practices.
- Conduct thorough compliance reviews of product labeling and claims, ensuring accuracy, legality, and adherence to regulatory guidelines.
- Provide essential support in the substantiation of structure/function claims, utilizing scientific data and regulatory knowledge to ensure compliance and credibility.
- Actively drive, lead and participate in regulatory audits and inspections, providing necessary documentation and support to demonstrate compliance with relevant regulations and standards.
Contribute to the continuous improvement of regulatory processes and quality systems, identifying opportunities for enhancement and implementing effective solutions to drive efficiency and effectiveness.
Requirements
- Bachelor's degree in a relevant field such as Regulatory Affairs, Quality Assurance, Chemistry, Biology, Pharmacy, or a related discipline. Advanced degree (e.g., Master's or Ph.D.) preferred.
- Minimum of 5 years of experience in regulatory affairs and/or quality assurance within the dietary supplement, pharmaceutical, or related industries.
- In-depth knowledge of FDA regulations, Good Manufacturing Practices (GMP), and other relevant regulatory requirements governing the production and distribution of dietary supplements.
- Proven experience developing and maintaining compliance documents, such as product safety protocols, SOPs, and regulatory submissions.
- Experience in health care manufacturing, preferably of dietary supplements, and demonstrable knowledge of relevant quality systems
- Knowledge of the industry’s regulatory environment, specifically with 21 CFR 111. Experience with quality audits and with the FDA is a plus.
- Familiarity with lean manufacturing principles and of solid-dosed, liquid, and powder manufacturing processes, machinery & equipment.
- Experience in managing cross-functional teams commonly found in a manufacturing organization
- Knowledge of laboratory and manufacturing information systems. Familiarity with laboratory (analytical and microbiology) instrumentation, notably including HPLC, GC, FTIR, ICP-OES and ICP-MS is a plus
- Excellent organizational, and communication skills. Experienced, yet energetic, and innovative.
- Strong communication, presentation and teamwork skills. Track record of performing all duties with a sense of urgency and proactive in communications.
- Good knowledge of D365 ERP is preferred
- Proficient in MS Word, Excel and PowerPoint
Thailand only
