China Technical Regulatory (CMC) Policy Lead

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 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.