Director, Technical Regulatory

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Job Description

• Single point of contact for CMC topics and issues related to China submission for assigned products.
• Accountable for development, communication and execution of sound regulatory strategies for early stage CTA 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 local and global teams.
• End to end manage early stage CTA and related submissions (CMC amendment, DSUR), including (but not limited to) lead CMC strategy discussion, dossier & documents preparation, submission, QnA, RIM, CTN etc.
• Lead response strategy to China Health Authority questions and support tracking of CMC commitments.
• Leading and/or coordinating health authority interactions for assigned projects.
• Ensuring up-to-date China regulatory requirements are maintained, communicated and integrated into project teams work plan, and proactively prepare for new requirements.
• Work together with PDR China Partner to ensure “One Regulatory Voice” in creating strategy and coordinating submission activities.
• Partner with China Policy to identify opportunities to shape the regulatory requirements around technical topics interested in Roche.
• Accountable for post approval CMC changes, NDA/BLA, CMC process build/improvement as appropriate.

QUALIFICATIONS

Education

Degree in relevant technical areas (Analytical, Biochemistry, Biology, Pharmacy). Master Degree is preferred.

Experience

• 8 or more years of work experience in the pharmaceutical industry. 5 or more years of CMC RA experience.
• Strong proven experience in Regulatory Affairs with focus on early stage CTA submission, and CMC requirements for small molecule/biologic products, development, manufacturing and/or quality experience.
• Technical background or experience of diverse modalities is a plus, e.g., ATMP, ADC, oligo, peptide.
• Global CTA submission (US, EU, Canada, South Korea, etc) experience is a plus.

Knowledge/Skills/Competencies

• Demonstrates effective problem-solving ability, has a strong understanding of regulatory strategies, shows excellent interpersonal skills and has the ability to prioritize multiple tasks.
• Has proven ability to influence and work both independently and collaboratively in a team structure.
• Strong knowledge of ICH and China regulations and guidelines. Knowledge of EMA, FDA, Canada regulations and guidelines is a plus.
• Strong verbal and written communication skills.
• Fluent in English and Chinese.

Who we are

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.