Regulatory Affairs
3 months ago
Responsible for managing and submitting regulatory filing materials, communicating with government departments, and handling matters related to regulatory filing strategies.
- Ensure compliance with local, national, and international regulatory requirements for company products, and develop **Corporate Regulatory Manuals & Guidelines** as company standards and procedures.
- Act as a liaison between the company and regulatory authorities, stay up-to-date with regulatory changes, and communicate the implications to relevant stakeholders.
- **Regulatory Compliance**: Supervise and audit product compliance with local production and operation regulations in the target country.
- **Registration and Certification Management**: Manage the registration process, including preparing and submitting necessary documentation to regulatory authorities, and coordinate with inspection agencies for product testing and certification.
**Job Requirements**:
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, or a related field.
- At least 3 years of experience in regulatory affairs or a related position,
- Proven experience in quality management systems, safety, and occupational health management, preferably in a manufacturing or industrial environment.
- Experience in handling **drugs registration is a must**, medical devices/food supplement related experience is a plus.
- Proficiency in managing intellectual property, including patents and trademarks.
- Strong analytical and problem-solving skills, negotiation abilities, and attention to detail.
- Maintain good relationships with BPOM (Indonesian FDA) and the Ministry of Health.
- Ability to lead and conduct internal audits and management reviews.
- Excellent verbal and written communication skills in English and Bahasa.
- Willing to work full-time from the office in jakarta.
**Education**:
- S1 (preferred)
**Experience**:
- Regulatory Affairs: 3 years (required)
**Language**:
- english (required)
**Location**:
- Jakarta (required)
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