生命科学职位 - 生命科学 - 法规事务类别

This position focuses on managing regulatory affairs for FSMP (Food for Special Medical Purpose) products in China. The role ensures timely registration, compliance, and strategic regulatory planning without direct team management responsibilities.

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.

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 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.

This role is responsible for managing regulatory-related activities in China to support business operations and mitigate uncertainties. It plays a critical role in ensuring regulatory compliance for product importation into the Chinese market and actively participates in market-related activities, including compliance assurance and crisis management from a regulatory affairs perspective.

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.

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.

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.