Duties & Responsibilities

• 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 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.

Skills & Competencies

• 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.

Educational / Work Experiences

• 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;

• 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.