中国职位 - 生命科学 - 法规事务类别

负责制定和推动公司全球注册战略，统筹创新药、高端仿制药及生物药在中国、欧美等国际市场的注册申报、监管沟通及药政体系建设，支持产品全球上市

知名MNC平台，深度参与创新药从研发到临床转化的关键节点。

国际注册总监负责制定并执行公司药品/生物制品全球注册战略，主导FDA、EMA等重点市场的注册申报与法规合规管理，推动产品高效获得国际上市批准。

The Regulatory Affairs Manager will lead regulatory activities in China, ensuring product compliance, registration execution, and effective engagement with regulatory authorities and external partners.

This role serves as a key business partner to commercial, quality, innovation, supply chain, and global regulatory teams, supporting market access and long-term portfolio growth.

Lead regulatory affairs activities for Thailand operations and support market access, product compliance, and registration activities across key ASEAN markets.

Serve as the regional regulatory expert, providing strategic guidance on formulations, ingredients, claims, labeling, and regulatory pathways for both local and export markets.

1.Provide End to End regulatory expertise to innovation projects in China R&D.
2.Ensuring compliance of raw materials and finished cosmetic products developed in line with chemical and cosmetic regulations in China and Asian countries.

As RAQA Manager, you will be responsible for driving the regulatory and quality strategy for China registration of a Class II active medical device. You will collaborate closely with cross-functional teams and external stakeholders to ensure timely and compliant market entry.

This role oversees end-to-end regulatory affairs for the China business: market entry, standards and labeling, claims and packaging compliance, risk identification and response, and professional engagement with authorities and industry bodies. It requires managing multiple projects in a fast-paced, results-oriented environment and partnering with R&D, FSQ, Marketing, Legal and Supply Chain to secure compliance across the product lifecycle.

Lead the development and execution of China region regulatory compliance initiatives, annual plan and budget, relevant company Standards compliance and audits, submit documents and reports into systems and global RA function, and related issues management.
This position also acts proactively and strategically, identifies potential regulatory issues and trends, develop strategies, drive effective approach and advocacy.

This role focuses on regulatory compliance for Third-Party Manufacturing (TPM) projects, ensuring raw materials and formulas meet all applicable standards. It requires strong communication skills to coordinate with R&D teams, TPM suppliers, and global regulatory counterparts, while optimizing processes for efficiency.

The Global Regulatory Affairs function maximizes opportunity & minimizes risk by guiding business decisions based on scientific & regulatory insight to ensure the freedom to launch these new innovations.
The Regulatory Manager will develop and implement the regulatory strategy for novel ingredients and products to ensure successful and timely launch in APAC markets.

The Head of APAC Regulatory Affairs leads the APAC Regulatory Team and work collaboratively with cross functional partners to support the company's regional and global objectives by enabling continuous market access of the existing portfolio and innovations.