Keterangan Kerja
Penerangan
- Ensures compliance with regulatory requirements and standards in the industry.
- Developing and implementing regulatory strategies, collaborating with cross-functional teams,and ensuring that products and processes meet all relevant regulatory guidelines.
- Develop new tools, standards, and approaches to assess the safety, efficacy, quality andperformance 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 forthe organization.
- Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensurethat 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 documentationto ensure compliance with regulatory requirements.
- Provide regulatory guidance and support to internal stakeholders, including productdevelopment teams, to ensure that regulatory requirements are incorporated into thedevelopment process.
- Monitor and track regulatory compliance metrics and provide regular reports to seniormanagement.
- Maintain a thorough understanding of international regulations in relevant markets and guidethe organization regarding international expansion plans.
Syarat-syarat
- In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISOstandards, and other applicable regional regulations;
- Strong understanding of quality systems and the ability to apply regulatory requirements toquality management processes.
- 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 obtainingregulatory approvals for products;
- Experience in developing and maintaining regulatory compliance documentation, includingtechnical files, regulatory dossiers, and other relevant documentation;
- Experience in interacting with regulatory authorities and managing regulatory inspections andaudits.
scientific
Aisa Refugia
Dempsey Resource Management Inc.
Balas Hari Ini 0 Kali
Tempat Bertugas
Calauan. Calauan, Laguna, Philippines
Disiarkan pada 02 May 2025