Regulatory Affairs Specialist

6 days ago


Kuala Lumpur, Malaysia Ziwell Medical Sdn Bhd Full time

**KEY FUNCTIONS**

Develop regulatory strategies, handle and oversea regulatory submissions, such as product registrations, renewals, variations and post-market surveillance reports.

Stay updated on changes in regulatory requirements and ensure organisation’s compliance with regulatory guidelines.

Support and evaluate business development projects, including early pipeline products, from RA perspective.

**CORE RESPONSIBILITIES**

1. Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.

2. Review registration dossiers, devise strategies for documentary gaps and ensure timely submissions and response to regulatory authorities’ queries. This includes, but not limited to, product registrations, notifications, renewals, variations and post-market surveillance reports.

3. Ensure regulatory submissions comply with regulatory requirements.

4. Stay updated on changes in regulatory requirements (both locally and globally) and translate them into actionable steps for the organization.

5. Liaise with regulatory authorities and serve as a point of contact during inspections, audits, and regulatory agency interactions.

6. Develop and maintain company’s SOPs to ensure adherence with regulatory guidelines.

7. Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.

8. Provide regulatory guidance and support to internal stakeholders, including marketing team, to ensure that regulatory requirements are incorporated into the development process.

**Qualifications**:

- Bachelor’s degree in Pharmacy, Science, Engineering or related field.
- Minimum 2 years of regulatory experience in the pharmaceutical industry
- Analytical ability: Strategic thinking, analytical and problem-solving skills.

**Job Types**: Full-time, Permanent

Pay: RM7,000.00 - RM9,000.00 per month

Schedule:

- Monday to Friday

Supplemental Pay:

- Performance bonus

**Education**:

- Bachelor's (required)

**Experience**:

- Regulatory Affairs: 2 years (required)



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