Scientific and Regulatory Affairs Associate

Dempsey Resource Management Inc.

RM2.4-2.8K[Bulanan]

Di lokasi - Laguna>10 Tahun PengalamanSarjana MudaSepenuh-masa

Kongsi

Keterangan Kerja

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.

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