Job Title: RAQA Manager (Regulatory Affairs, Quality Assurance)
Location: Kuala Lumpur, Malaysia
Working Arrangement: On-site
Job Summary: We are seeking an experienced RAQA Manager in Kuala Lumpur. The ideal candidate will have a strong background in regulatory affairs and quality assurance within the pharmaceutical or consumer health sectors. This role involves working closely with distributors, conducting audits, and ensuring compliance with regional regulations.
Key Responsibilities:
- Oversee regulatory affairs and quality assurance activities to ensure compliance with local and international standards.
- Manage relationships with distributors, including conducting regular audits and compliance checks.
- Develop and implement quality assurance policies and procedures.
- Ensure all products meet regulatory requirements and quality standards.
- Provide guidance and support to internal teams on regulatory and quality matters.
- Stay updated on regulatory changes and ensure the company's practices are aligned with current regulations.
- Prepare and submit regulatory documents to relevant authorities.
- Coordinate with regional teams in Malaysia and SEA region to ensure consistent quality and regulatory practices.
Key Criteria:
- 5+ years of experience in regulatory affairs and quality assurance in the pharmaceutical or consumer health industry.
- Proven experience in working with distributors and conducting audits.
- Regional experience in Malaysia and SEA region is preferred.
- Strong understanding of local and international regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to work independently and manage multiple projects simultaneously.
- Detail-oriented with strong analytical and problem-solving skills.
