Project Regulatory Affairs Specialist - Johor Bahru, Malaysia - Hemo Bioengineering Pte Ltd

Description

• Stay abreast of local and international regulatory requirements related to the project.
• Monitor changes in regulations and communicate updates to relevant stakeholders.
• Assist in developing projectspecific strategies to ensure ongoing compliance with regulatory standards.

• Maintain accurate and uptodate regulatory documentation for the project, ensuring accessibility for audits.

• Act as a liaison between the company and regulatory agencies for matters specific to the project.
• Respond to queries and requests for additional information from regulatory authorities promptly.

• Collaborate with quality assurance teams to ensure projectrelated products meet regulatory standards.
• Participate in internal and external quality audits related to regulatory affairs for the project.

• Review and approve product labeling and packaging materials for compliance with regulatory requirements for the project.

• Work closely with crossfunctional teams involved in the project, including R&D, marketing, and legal, to ensure regulatory considerations are integrated into project strategies.

• Conduct regulatory intelligence activities specific to the project to anticipate regulatory trends and potential impacts.
• Engage in research work related to product development, manufacturing, and intellectual property within the scope of the project.

• Bachelor's degree in a relevant scientific or regulatory field.
• Proven experience as a Regulatory Affairs Specialist
• Strong understanding of local and international regulatory frameworks.
• Experience in intellectual propertyrelated work.
• Excellent written and verbal communication skills.
• Detailoriented with a commitment to maintaining accurate and organized records.
• Ability to work independently and collaboratively in a fastpaced environment.

The initial contract period will be 12 months, with the possibility of extension based on the project timeline, performance, and business needs.

• Monday to Friday

• Mandarin (required)