Senior Regulatory Affairs CMC Manager
3 weeks ago
Key Responsibilities:
As a Senior Regulatory Affairs CMC Manager at 1215 GlaxoSmithKline (China) Investment Co Ltd, you will be responsible for providing strategic and technical regulatory input for the purpose of commencing and maximizing GSK China business by facilitating the CMC submission and approval in a timely and high-quality manner.
Key Accountabilities:
- Develop and implement CMC regulatory strategies for new and established products.
- Provide regulatory support for CMC document preparation, CDE CMC technical review follow-up, HA CMC meeting or communication for CMC topics, QC testing, GMP on-site inspection, ChP, bundling review, etc.
- Collaborate with internal stakeholders to ensure timely and high-quality CMC filing and approval.
- Establish and maintain relationships with key CMC regulatory authorities in China.
- Ensure compliance with company SOPs and regulatory requirements.
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