Regulatory Affairs ManagerLBE Pharma Tech. Co, Ltd

Regulatory Affairs Manager

Job Responsibilities:

1. Lead domestic and international product registration submissions, including document preparation, compilation, submission, and end-to-end tracking of the entire registration process.

2. Monitor updates in global pharmaceutical regulations and technical guidelines; interpret changes and guide internal compliance implementation.

3. Coordinate cross-functional teams (R&D, production, quality, clinical) to ensure regulatory compliance of registration materials.

4. Liaise with regulatory authorities (e.g., China NMPA, U.S. FDA, European EMA) to address technical queries and expedite review processes.

5. Develop or contribute to registration strategies, assess regulatory risks, and propose mitigation plans.

6. Manage external partners (e.g., CROs, consultants) to ensure efficient project execution.

7. Conduct internal team training to enhance regulatory awareness and registration expertise.

Qualifications:

1. Bachelor’s degree or higher in Pharmacy, Pharmaceutical Engineering, Biotechnology, Clinical Medicine, or related fields (Master’s/PhD preferred).

2. 3-5 years of pharmaceutical registration experience, with proven success in full-cycle submissions for at least one major market (China, U.S., or EU).

3. Excellent English proficiency (written and spoken) for handling international registration documentation.

4. Preferred:

- Team management experience.

- Hands-on experience with FDA/EMA submissions.

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