Scientific and Regulatory Affairs Associate

Dempsey Resource Management Inc.

C$860-982[Monthly]
On-site - Laguna>10 Yrs ExpBachelorFull-time
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Job Description

Description

  • 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.


Requirements

  • 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.
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Aisa Refugia

Dempsey Resource Management Inc.

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Working Location

Calauan. Calauan, Laguna, Philippines

Posted on 02 May 2025

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