Project Regulatory Affairs

3 days ago

Remote, Singapore 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 project-specific strategies to ensure ongoing compliance with regulatory standards.
- **Documentation and Submission**:

- 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**:

- Diploma Holder 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

Pay: $2,000.00 - $3,000.00 per month

Schedule:

- Monday to Friday

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