International Registration of Drugs

Pharmacy, Pharmaceutical Sciences, Biopharmaceuticals, Molecular Biology, Pharmaceutical Analysis, and related fields

Master's degree or higher

1. Educational Background: Master’s degree or higher in Pharmacy, Pharmaceutical Sciences, Biopharmaceuticals, Molecular Biology, Pharmaceutical Analysis, or a related field. Candidates with professional experience in the R&D or regulatory affairs of small nucleic acids, peptides, or sterile formulations will be given priority.

2. Core Experience: Solid experience in international drug registration submissions; familiarity with the submission rules and processes of major international regulatory agencies such as the FDA and EMA; Proficient in the entire process of drug R&D, pilot-scale scale-up, and commercial manufacturing, as well as CMC compliance requirements; capable of independently coordinating registration project management and managing multiple projects concurrently.

3. Preferred Qualifications: Experience with international registration of peptides and sterile biopharmaceutical formulations; preference given to candidates with a track record of successful domestic and international IND/NDA submissions for small nucleic acid drugs such as siRNA and ASO; familiarity with the characteristics of small nucleic acid drug formulations, aseptic manufacturing standards, and specific regulatory requirements.

4. Language Skills: Excellent English proficiency; able to read and write regulatory documents and technical materials in English fluently; capable of independently drafting English regulatory submission documents and communicating seamlessly with overseas regulatory agencies and international partners.

5. General Competencies: Possesses keen regulatory interpretation skills, risk assessment abilities, and problem-solving skills; demonstrates clear logic and a strong sense of responsibility; excels in cross-departmental communication and coordination, project management, and teamwork; capable of efficiently addressing various unexpected issues that arise during the regulatory submission process.

6. Professional Ethics: Familiar with the GXP compliance system for pharmaceuticals; possesses a meticulous and rigorous work ethic, strong execution capabilities, and high professional integrity; aligns with the pace of the innovative drug R&D industry and can adapt to the phased demands of

1

 Drug Registration

Pharmacy, pharmacology, and related fields

Bachelor's degree or higher

1. Bachelor’s degree or higher in pharmacy, pharmacology, or a related field, with at least 2 years of experience in regulatory affairs.

2. Self-motivated learner with strong logical thinking, teamwork, and communication skills.

3. Fluent in English, able to independently read, write, and translate technical documents, and capable of everyday spoken communication.

1