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Primary duties and responsibilities
Single point of contact for CMC topics and issues related to China submission for a specific product.
Accountable for development, communication and execution of sound regulatory strategies for CTA, NDA/BLA, and life cycle management submissions that meet China regulatory requirements and enable business objectives.
Identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.
Liaise with PT functions, eg. Supply Chain, Quality for development and execution of technical strategy, maximizing and balancing regulatory and supply needs in China and enabling, prioritization of change management activities.
Lead response strategy to China Health Authority questions and support tracking of CMC commitments.
Leading and/or coordinating health authority interactions for assigned projects.
Accountable for development and implementation of sample testing strategy to ensure timely handover of analytical methods to government lab.
Ensuring up-to-date China regulatory requirements are maintained, communicated and integrated into project teams work plan, and proactively prepare TRT for new requirements.
Work together with PDR China Partner to ensure “One Regulatory Voice” in creating strategy and coordinating submission activities.
Qualifications
Education
Bachelor’s Degree or above in relevant technical areas (Analytical, Biochemistry, Biology). Master's degree is preferred.
Experience
At least 2 years work experience in analytical, CMC, or RA areas.
Biological manufacturing&analysis experience is preferred.
Experience in Regulatory Affairs with focus on CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance experience is a plus.
Knowledge/Skills/Competencies
Demonstrates effective problem-solving ability, shows excellent interpersonal skills and has the ability to prioritize multiple tasks
Strong knowledge of pharmacopoeia (ChP, USP, EP), China regulations and guidance. Knowledge of regulations and guidelines of other major markets (e.g. FDA, EMA) is a plus
Has proven ability to influence and work both independently and collaboratively in a team structure
Strong verbal and written communication skills
Fluent in English and Chinese
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
