Global Regulatory Affairs Leader
11 hours ago
We are seeking a highly skilled Global Regulatory Affairs Leader to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd. As a key member of our organization, you will be responsible for providing strategic and technical regulatory support to our line manager.
Key Responsibilities:
- Provide high-quality regulatory input and advice on general regulatory topics, contributing to decision-making on drug development strategy and license maintaining strategy.
- Independently compile filing documents complying with external and internal requirements to provide accurate and clear drug profiles and data to the National Medical Products Administration (NMPA).
- Engage with internal and external stakeholders to ensure timely issue resolution and target filing and approval timeline achievement.
- Establish and maintain good relationships with key regulatory authorities, such as NMPA, CDE, NIFDC, CPC, etc., via professional communication.
Qualifications/Requirements:
- A minimum of a bachelor's degree in chemistry or biological sciences.
- At least 8 years' experience in regulatory affairs, with a minimum of 5 years in a multinational company.
- Proven ability to communicate effectively with various functions and authorities.
- Fluency in English and Mandarin Chinese.
Salary Information:
The estimated annual salary for this position is around $120,000-$180,000, depending on qualifications and experience. This figure is based on industry standards and location factors.
About Us:
1215 GlaxoSmithKline (China) Investment Co Ltd is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. We aim to positively impact the health of billions of people worldwide.
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