Position Overview:
We are seeking a qualified Regulatory Affairs Specialist to join our team on a project-based contractual basis with a focus on research in product development and manufacturing. The selected candidate will play a crucial role in ensuring compliance with regulatory requirements, conducting intellectual property-related work, and supporting research activities for the specific project.
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 project-specific strategies to ensure ongoing compliance with regulatory standards.
- Documentation and Submission:
- Prepare and submit regulatory documents and applications for product registrations related to the project.
- Maintain accurate and up-to-date 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 project-related 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 cross-functional 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.
- FRESH Graduates are welcome!
- Excellent written and verbal communication skills.
- Detail-oriented with a commitment to maintaining accurate and organized records.
- Ability to work independently and collaboratively in a fast-paced environment.
- Able to Work From Home
Job Types: Contract, Freelance
Contract length: 12 months
Pay: RM3,000.00 - RM5,000.00 per month
Benefits:
- Flexible schedule
- Opportunities for promotion
- Professional development
Schedule:
- Monday to Friday
Work Location: Remote
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