Position: Registration Manager
Industry: Biopharma
Perm
Description:
- Manage product registration in Singapore and Southeast Asia.
- Understand the full development process for innovative and generic drugs, as well as medical devices.
- Identify and mitigate risks during registration and drive projects to align with company goals.
- Coordinate with internal teams, partners, and organizations for project planning and management.
- Collect, prepare, and submit registration documents as required by Southeast Asian regulatory authorities.
- Monitor the review process of registration submissions and address queries promptly, ensuring clear communication with regulatory bodies and partners.
- Assist in preparing and supporting GMP audits based on the requirements of Southeast Asian regulatory agencies.
Requirements:
- Master’s degree or higher in Biology, Pharmacy, Clinical Medicine, or related fields.
- Minimum of three years’ experience in product registration within Southeast Asia, with preference for candidates with independent registration success.
- Familiarity with pharmaceutical regulations and submission processes in Southeast Asia.
- Strong English communication skills (written and spoken) and fluency in Chinese.
- Strong learning, communication, and project management skills with the ability to handle and resolve issues in the registration process.
(EA:20C0196)
R22108971
