Scientific and Regulatory Affairs Manager

Graduate of Bachelor in Science degree in Scientific Discipline,

ii. Master’s Degree is an advantage.
b. Years & Type of Experience:
i. At least ten (10) years of relevant and related work experiences
as a Scientific and Regulatory Affairs Manager in the food
manufacturing industry;
ii. Proven track record of successfully developing and executing
regulatory strategies and obtaining regulatory approvals for
products;
iii. Experience in developing and maintaining regulatory
compliance documentation, including technical files, regulatory
dossiers, and other relevant documentation;
iv. Experience in interacting with regulatory authorities and
managing regulatory inspections and audits.

c. Certifications & Licenses:
i. Professional certifications in regulatory affairs is an advantage.
d. Skills & Competencies:
i. In-depth knowledge of relevant regulations and standards, such
as FDA regulations, ISO standards, and other applicable
regional regulations;
ii. Strong understanding of quality systems and the ability to apply
regulatory requirements to quality management processes.

III. JOB PURPOSE
 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.

IV. KEY RESPONSIBILITIES:
a. Develop new tools, standards, and approaches to assess the safety,
efficacy, quality and performance of all products.
b. Develop and execute regulatory strategies and plans to ensure
compliance with applicable laws, regulations, and standards.
c. Stay updated on changes in regulatory requirements and translate
them into actionable steps for the organization.
d. Collaborate with cross-functional teams including R&D, Quality
Assurance, and Legal to ensure that all regulatory requirements are
met throughout the product lifecycle.
e. Prepare and submit regulatory submissions, including but not limited
to, product registrations, pre-market notifications, and post-market
surveillance reports.
f. Liaise with regulatory authorities and act as the primary point of contact
during inspections, audits, and regulatory agency interactions.
g. Conduct risk assessments and develop mitigation strategies to manage
regulatory risks.
h. Review and approve product labelling, promotional materials, and other
relevant documentation to ensure compliance with regulatory
requirements.
i. Provide regulatory guidance and support to internal stakeholders,
including product development teams, to ensure that regulatory
requirements are incorporated into the development process.
j. Monitor and track regulatory compliance metrics and provide regular
reports to senior management.
k. Maintain a thorough understanding of international regulations in
relevant markets and guide the organization regarding international
expansion plans.