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 people leader leads a team of China Technical Partners (CTPs) and CMC professionals that are accountable for China regulatory CMC submissions, through developing and implementing robust end-to-end China filing strategies based on close collaboration with global development teams, China business priorities, China regulatory requirements and landscape. The scope includes the complete Roche portfolio, the global products (small molecules, biologics, new modalities). The focus of this role is to lead and coach the team members in order to accelerate drug access and continuous supply to the patients by ensuring right first-time submissions to Chinese Health Authorities and effective interactions with the Health Authority. The incumbent of the role is responsible to shape the regulatory environment in China in close collaboration with PTR Policy and translate that into innovative regulatory strategies. In line with Roche’s China strategy and the China First initiative, this is a role with a high business impact.
In this position, the people leader is responsible for the management of China Technical Partners (CTPs) and CMC program managers, which includes setting performance objectives, providing timely feedback, and ensuring alignment of short-term development goals with longer-term career goals. Provides guidance and manages work activities of others for specific projects and/or objectives. Demonstrates the fundamentals of effective coaching skills and mentoring. Adapts coaching style to meet the needs of the individual.
The people leader leads cross-functional regulatory initiatives and strategies, defines associated critical steps and resources needed and takes responsibility for implementation of these initiatives and strategies. Proactively communicates with regulatory and cross-functional personnel in support of internal and partner-associated project goals. Collaborates with management in leading communications with HA on projects and initiatives of major complexity. Makes decisions based on cross-functional priorities rather than functional area priorities.
Project People Leader
- Provide leadership to a team of regulatory professionals.
- Responsible for performance management of employees.
- Work with direct reports and ensure that objective and timely feedback is provided to employees, focus on the development of the employee by facilitating regular development discussions and check-ins.
- Provide coaching and mentoring to colleagues for an assigned area of technical regulatory responsibility.
- Work closely with the Portfolio Leader to coordinate resources and priorities at a Portfolio level.
- Regularly follow up and check in the progress of every specific project in the team, enlighten the team to work out submission strategies for different applications and identify regulatory risks and develop migration plans.
- Build and maintain a healthy relationships with internal& external key stakeholders, like NMPA, CDE, NIFDC, Supply Chain, Quality and compliance, PDR China and PTR global,
- Collaborate with internal key stakeholders for development and alignment of technical strategy, maximizing and balancing regulatory and supply needs in China.
QUALIFICATIONS
Education
Master’s Degree in life science disciplines is preferred; Post Graduate Degree is a plus.
Experience
- 8 or more years work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory or related experience.
- Previous People management or cross-functional team leadership experience is desired.
Knowledge/Skills/Competencies
- Regulatory Strategy and Operational Knowledge / Business Acumen
- Proven knowledge of China Health Authority guidelines and experience in interacting
- with health authorities.
- Proven track record to develop regulatory strategies and scenario planning with robust regulatory risk assessment.
- Technical understanding of drug substance and product manufacturing, in one or both modalities
- SM and LM and product development processes, as appropriate.
- Knowledge of drug development, commercialization process, supply chain complexity and
- Pharmaceutical Quality Systems and knowledge of multidisciplinary functions involved in drug development (all functions), manufacturing, commercialization and product lifecycle management.
- Operate with an agile mindset and drive for continuous improvement.
Collaborations and Leadership
- Able to build and maintain productive and trusted relationships within/across departments as well as with external partnerships and regulators, between companies and cultures.
- Proven track record of team leadership, preferably cross-functional teams.
- Ability to develop people through coaching
- Outstanding organizational and time management skills; proven ability to work under pressure.
- Exceptional influencing and negotiation skills: extracts optimized business results through skillful collaboration with others (at all levels and across organizations) without formal authority and is highly adept at identifying solutions that will balance the needs of all parties involved.
- Excellent interpersonal and collaboration skills: proven track record of building strong and sustainable relationships with internal and external partners/stakeholders.
- Demonstrates, or has proven abilities to demonstrate Roche Values and Leadership Competencies.
- Communication
- Excellent communication and presentation skills: exhibits professional maturity, confidence and competence.
- Able to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making.
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.
