China Technical Regulatory – Policy Lead - CMC

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

The Opportunity

• Provide Leadership, oversight and execution of technical regulatory policy activities for the Roche Pharma Group relevant to China including the development of Roche  policy positions on key topics relevant to Pharma Technical, and effective advocacy of such positions externally.

• Collaborate closely with the regulatory colleagues in China and globally  to develop and execute the China regulatory policy roadmap  

• Ensure alignment  and stakeholder engagement within Pharma Technical Operations, Product Development, Pharma International, governmental affairs  as well as external interest groups

Key Responsibilities and Tasks

Identify and enable  regulatory policy activities in China such that Roche is globally recognized as an industry leader with health authority agencies and industry peer groups and that significant value is realized in facilitating pipeline development, marketing authorizations and excellence in manufacturing

Build and maintain relationships based on trust and respect with key health authority professionals, relevant academic and opinion leaders and non-profit scientific associations

Establish a strong partnership and networks with internal (i.e. Regulatory, Technical, Quality, Medical,, Gov. Affairs ) and external stakeholders

Ensure the development, execution and communication of the China regulatory policy roadmap

Lead strong cross-functional teams and regional/global regulatory communities of practice to drive policy change in China 

Represent Roche technical regulatory policy views in China (and beyond) during external stakeholder engagement

 Take leadership in  local, regional and/or global associations (e.g. RDPAC, BIO, IFPMA…) and/or governmental organizations (e.g. APEC, ICH) in line with the Roche positions .

Provide leadership and consultancy to Roche Pharma Division leaders  on regulatory policy and strategy related topics affecting China

Act as subject matter expert for key technical  regulatory policy and strategy areas as assigned, lead the development of specified Global Regulatory Policy positions in close collaboration with SMEs.

Build influencing and advocacy knowledge and capacity and empowers other colleagues to shape the regulatory environment 

Core Competencies, Skills
 Excellent collaboration skills

Recognized expert in relevant CMC technical/regulatory area with established external credibility as thought leader

Proven ability to build and maintain strong relationships with global health authorities

Strong team player and communicator

Creates an environment of strong team spirit, good communication, high motivation, inspire cross-functional project teams

Excellent advocacy, communication and presentation skills

Strategic thinking and analytical skills,  ability to simplify complex topics and to pull it all together to strategic planning.

Challenges the status quo to drive innovation 

Ability to operate successfully in a global matrix environment with shared accountability and responsibilities.

Minimum Qualifications and Experience
 

Degree in relevant technical area ( Analytical, Biochemistry, Biology, Pharmacy)

At least 10 years of work experience in relevant area  or advanced degree (PhD) in relevant technical area combined with a minimum of 5 yrs  work experience

Previous experience in Regulatory (Industry or Agency) is preferred 

In depth Knowledge of China regulatory environment

Previous participation and proven effectiveness in international regulatory/industry forums is highly preferred

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.