Regulatory Affairs Specialist - Submission Management

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

eCTD Expertise

● Solid knowledge of regulatory agency requirements for electronic submissions format and delivery including profuse knowledge of eCTD specifications and validation requirements.

● Practical hands-on experiences in executing eCTD applications involving the assembly, formatting, publishing and submissions of regulatory dossiers with HAs.

● Expertise in eCTD publishing process and tools, submission software, documents management systems; proficiency with relevant IT tools, especially MS Office programs (Word, Excel) and Adobe Acrobat; experience of working with RIM/Veeva Vault systems is a plus.

● Motivated self-starter with the sensitivity to detect potential impact raised by regulation change and the ability to identify opportunities for process improvement.

Operational Excellence

● Ability to effectively plan, execute, and monitor projects from initiation to completion with minimum guide.

● Capability to collaborate with diverse stakeholders to ensure alignment and support, by building and maintaining trustful and strong relationships, proactively managing stakeholder expectations, with strong interpersonal and communication skills to influence and negotiate effectively.

● Ability to work effectively within a team and across departments to achieve common goals, by developing and cultivating robust relationships with colleagues at all levels of the organization, fostering a collaborative work environment inclusively, supporting team members by sharing knowledge and providing technical-shooting assistance/insights inputs, etc.

● A strong commitment to continuous learning and self-improvement, with a demonstrated ability to quickly manage usage of new systems and tools, acquire new knowledge and skills, adapt to changing environments, stay updated with industry trends and best practices; and the ability to learn from feedback and incorporate it into personal and professional growth.

Education/Qualifications

• B.S. or above in Pharmacy, Medical, Biology or related field

Relevant working experience:

> 3 years’ experience in Pharma MNCs, including at least 2 years in regulatory submissions • Experience in delivering eCTD submissions is required • Independent working • Experiences in crisis management

Language and PC Skills: • Chinese (mother-tone level) and English (proficiency level) • Digital mindset and good computer skill/information management skill/project management skill

Travel Frequency <25%

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.