Senior Manager CMC Regulatory Affairs Professional
1 month ago
We are seeking a Senior Manager CMC Regulatory Affairs Professional to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd.
Job SummaryThis role is responsible for providing strategic and technical regulatory input for new and established products, ensuring timely and high-quality CMC submissions and approvals in China.
Key Responsibilities:- Develop and implement CMC strategies for assigned products, including preparation of CMC documents and management of CDE CMC technical reviews.
- Provide regulatory input and support to line managers on new drug CMC development strategy and license maintaining CMC strategy.
- Compile high-quality CMC filing documents complying with external and internal requirements.
- Engage with internal and external stakeholders to ensure timely completion of CMC milestones and achievement of targeted labeling and drug features.
- Maintain good relationships with key CMC regulatory authorities in China.
- Provide timely and high-quality CMC regulatory support and input to internal stakeholders as needed.
- A minimum of master's degree in life science (pharmacy, chemistry, biology or related background).
- Minimum 6 years' experience in regulatory affairs/CMC field and at least 3 years in MNC.
- Proven ability to communicate effectively with various functions and with authority.
- Fluency in English and strong ownership and cross-boundary working mindset.
- A strong capability in problem solving and ability to coordinate, influence and lead a virtual team.
We offer a competitive salary and benefits package, including:
- An estimated annual salary range of RMB 600,000 - 800,000 based on qualifications and experience.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
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