1 Scientific Affairs jobs in the Philippines
Scientific & Regulatory Affairs Manager
Dempsey Resource Management Inc.
Posted today
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Job Description
Job description
Duties & Responsibilities: br>• Ensures compliance with regulatory requirements and standards in the industry. < r>• Developing and implementing regulatory strategies, collaborating with cross-functional teams, < r>and ensuring that products and processes meet all relevant regulatory guidelines.
• Develop new tools, standards, and approaches to assess the safety, efficacy, quality and < r>performance of all products.
• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, < r>regulations, and standards.
• Stay updated on changes in regulatory requirements and translate them in actionable steps for < r>the organization.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure < r>that all regulatory requirements are met throughout the product lifecycle.
• Prepare and submit regulatory submissions, including but not limited to, product registrations, < r>pre-market notifications, and post-market surveillance reports.
• Liaise with regulatory authorities and act as the primary point of contact during inspections, < r>audits, and regulatory agency interactions.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks. < r>• Review and approve product labelling, promotional materials, and other relevant documentation < r>to ensure compliance with regulatory requirements.
• Provide regulatory guidance and support to internal stakeholders, including product < r>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 < r>management.
• Maintain a thorough understanding of international regulations in relevant markets and guide < r>the organization regarding international expansion plans.
Skills & Competencies:
• In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISO < r>standards, and other applicable regional regulations;
• Strong understanding of quality systems and the ability to apply regulatory requirements to < r>quality management processes.
Educational / Work Experiences:
• Graduate of Bachelor in Science degree in Scientific Discipline, Engineering or related field < r>• Master’s Degree is an advantage
Affairs Manager in the food manufacturing industry;
• Proven track record of successfully developing and executing regulatory strategies and obtaining < r>regulatory approvals for products;
• Experience in developing and maintaining regulatory compliance documentation, including < r>technical files, regulatory dossiers, and other relevant documentation;
• Experience in interacting with regulatory authorities and managing regulatory inspections and < r>audits.
Willing to be assigned in Calauan, Laguna
Job Types: Full-time, Permanent
Duties & Responsibilities: br>• Ensures compliance with regulatory requirements and standards in the industry. < r>• Developing and implementing regulatory strategies, collaborating with cross-functional teams, < r>and ensuring that products and processes meet all relevant regulatory guidelines.
• Develop new tools, standards, and approaches to assess the safety, efficacy, quality and < r>performance of all products.
• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, < r>regulations, and standards.
• Stay updated on changes in regulatory requirements and translate them in actionable steps for < r>the organization.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure < r>that all regulatory requirements are met throughout the product lifecycle.
• Prepare and submit regulatory submissions, including but not limited to, product registrations, < r>pre-market notifications, and post-market surveillance reports.
• Liaise with regulatory authorities and act as the primary point of contact during inspections, < r>audits, and regulatory agency interactions.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks. < r>• Review and approve product labelling, promotional materials, and other relevant documentation < r>to ensure compliance with regulatory requirements.
• Provide regulatory guidance and support to internal stakeholders, including product < r>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 < r>management.
• Maintain a thorough understanding of international regulations in relevant markets and guide < r>the organization regarding international expansion plans.
Skills & Competencies:
• In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISO < r>standards, and other applicable regional regulations;
• Strong understanding of quality systems and the ability to apply regulatory requirements to < r>quality management processes.
Educational / Work Experiences:
• Graduate of Bachelor in Science degree in Scientific Discipline, Engineering or related field < r>• Master’s Degree is an advantage
Affairs Manager in the food manufacturing industry;
• Proven track record of successfully developing and executing regulatory strategies and obtaining < r>regulatory approvals for products;
• Experience in developing and maintaining regulatory compliance documentation, including < r>technical files, regulatory dossiers, and other relevant documentation;
• Experience in interacting with regulatory authorities and managing regulatory inspections and < r>audits.
Willing to be assigned in Calauan, Laguna
Job Types: Full-time, Permanent
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