Job Description:

• 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.
• Licensing and Export Documentation: Handle the application and renewal of production and business licenses, and manage the preparation and issuance of export sales certificates.
• Intellectual Property Management: Manage intellectual property matters, including patent applications, timely payment of patent fees, and trademark registration and renewal applications.

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.

Job Type: Full-time
Education:

• S1 (Preferred)

Experience:

• Regulatory Affairs: 3 years (Required)

Language:

• english (Required)

Location:

• Jakarta (Required)