Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
