Scientific & Regulatory Affairs Manager

• Ensure compliance with regulatory requirements and standards in the industry.
• Develope and implement regulatory strategies, collaborate with cross-functional teams, and ensure that products and processes meet all relevant regulatory guidelines.
• Develop new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all products.
• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
• Stay updated on changes in regulatory requirements and translate them in actionable steps for the organization.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.
• Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.
• Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
• Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
• Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.
• Monitor and track regulatory compliance metrics and provide regular reports to senior management.
• Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.

QUALIFICATIONS
• Graduate of Bachelor in Science degree in Scientific Discipline, Engineering or related field
• Master’s Degree is an advantage
• At least ten (10) years of relevant and related work experiences as a Scientific and Regulatory Affairs Manager in the food manufacturing industry;
• Proven track record of successfully developing and executing regulatory strategies and obtaining
regulatory approvals for products;
• In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISO standards, and other applicable regional regulations;
• Strong understanding of quality systems and the ability to apply regulatory requirements to quality management processes.
• Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation;
• Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
* Willing to be assigned in Calauan, Laguna