Associate Director Regulatory Affairs

Summary of Role：

• Be responsible for Viatris new import drugs (innovation, portfolio brand products and generics) registration, as well as maintaining post-approval products

• Serve as primary liaison with NMPA/CDE and support meetings, briefings, and negotiations, to enable timely approvals

• Provide RA professional support to cross-functional departments/teams

• Ensure compliance with national regulations and internal standards

• The position requires strong leadership, clear stakeholder influence, and deep knowledge of NMPA requirements.

• You will mentor team members, manage priorities across programs, and drive quality in documentation and processes.

Key Responsibilities：

As a team leader, be responsible for drug registration, lifecycle management and regulatory affairs related activities in China, this includes, but is not limited to, the following activities:

1. Be responsible for Viatris new imported drugs (innovation, portfolio brand products and generics) registration, including registration dossiers preparation, submission and follow-up in a timely manner, keep well communication with global colleagues and efficient communication with CDE staff/reviewers, so that to make sure to move project smoothly

2. Be responsible for maintaining currently marketed products, including submitting variations and license renew in time based on current regulation and practice, and closely follow up registration activities such as local testing and specification validation for registration purpose, response to deficiency letters during registration procedure etc.

3. Establish and maintain direct contact with global regulatory team for RA information share and provide timely local RA support to assure projects going on track and meet local requirements

4. Serve as primary liaison with NMPA/CDE and support meetings, briefings, and negotiations

5. Ability to identify regulatory risks, propose mitigation plans, and drive issue resolution

6. Ensure submission documentation accuracy, consistency, and compliance standards

7. Support labeling, packaging, and promotional review for regulatory compliance

8. Provide RA professional support to cross-functional teams

9. Complete tasks assigned by line manager

Education:

• Master's degree or above

• Preferred with MSc. in Pharmacy

Work Experience：

• 10 or more years of imported or local product regulatory experiences in related category, with 2 years or above team leader role

• Being qualified independently and effectively complete registration projects for assigned tasks, with extensive experience in innovative drug registration.

• Strong knowledge of imported or local drug registration, and familiar with NMPA regulations, policy, health system, registration procedure, and CDE requirements, as well as requirements in testing, importation etc.

• Knowledge of medicinal products regulations, policy in EMA, FDA, etc.

• Results oriented, excellent ability to analyze and solve different problems during the entire registration procedure, and fast self-study ability

• Good capability in verbal and written as well as presentative skills, in both English and Chinese