Project Regulatory Affairs Specialist

2 weeks ago


Johor Bahru, Johor, Malaysia Hemo Bioengineering Pte Ltd Full time

Position Overview:

Responsibilities:

-
Regulatory Compliance:

  • 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.
-
Documentation and Submission:

  • Maintain accurate and uptodate regulatory documentation for the project, ensuring accessibility for audits.
-
Communication with Regulatory Authorities:

  • 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.
-
Quality Assurance Support:

  • 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.
-
Labeling and Packaging Compliance:

  • Review and approve product labeling and packaging materials for compliance with regulatory requirements for the project.
-
Cross-functional Collaboration:

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

  • 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.

Qualifications:

  • 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.

Contract Duration:


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


Job Types:
Full-time, Contract

Contract length: 12 months

Salary:
RM3, RM5,000.00 per month

Schedule:

  • Monday to Friday

Language:

  • Mandarin (required)


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