Contract Opportunities

Senior Global Regulatory Affairs Lead – China

Contract: 52 weeks

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We are seeking an experienced Global Regulatory Affairs Leader with strong expertise in China regulatory requirements to support a global pharmaceutical development programme.

This is an exciting opportunity for a senior regulatory professional to provide strategic guidance and specialist support across China-specific regulatory pathways, clinical trial approvals and the alignment of regional regulatory requirements with broader global development and approval strategies.

Working alongside global cross-functional stakeholders, you will help navigate the evolving regulatory landscape in China and provide expert input as development programmes consider future clinical and global regulatory milestones.

The Role

Provide expert guidance on China regulatory strategy and requirements for clinical development programmes.
Support regulatory planning and clinical trial approval activities in China.
Advise on the alignment of China regulatory requirements with global development and approval strategies.
Provide strategic input as the organisation evaluates future clinical trial activity and potential global regulatory pathways.
Collaborate with global Regulatory Affairs teams and cross-functional stakeholders to address regulatory questions and emerging priorities.
Deliver targeted, ad hoc support in response to evolving programme needs.
What we're looking for
Significant experience in pharmaceutical Regulatory Affairs, with a strong understanding of China’s regulatory environment.
Demonstrable expertise in China clinical trial applications, regulatory submissions and approval pathways.
Experience supporting global development programmes and working across regional and international regulatory frameworks.
The ability to provide clear, pragmatic regulatory advice to senior stakeholders.
Strong communication and stakeholder-management skills, with the ability to work effectively across geographies and functions.
Fluency in Mandarin and English would be highly advantageous, particularly for engagement with local regulatory stakeholders.

Requirements

We are open to engaging an experienced professional based in New Jersey or China. We would welcome interest from China-based regulatory leaders as well as Chinese-speaking experts based in the US who have the relevant regional expertise and global regulatory experience.

The requirement is expected to be flexible and driven by programme needs, making it potentially well suited to an established consultant or senior regulatory professional seeking a targeted advisory engagement.