In Pharma Technical Regulatory (PTR), we develop and maintain our licenses globally and influence Health Authorities in their thought processes to develop regulations.
As the Head of Pharma Technical Regulatory, you will be a member of the Global Pharma Technical Operations (PT) Leadership team and report directly to the Head of Global Pharma Technical Operations. You will lead a global, multilayered organization of about 350 FTEs with approximately 8 direct reports, managing a budget of around 100 million CHF.
You will work collaboratively within the PT leadership team to establish priorities and strategic direction to meet business needs and achieve long-term goals.
You will be responsible for the quality of all Regulatory Applications, including initial global Marketing Authorizations for Roche’s portfolio, and for interactions with global Health Authorities related to CMC aspects. You are expected to be a thought leader, shaping the regulatory environment and developing innovative concepts to support PT’s mission.
Key responsibilities :
1. Develop and execute regulatory strategies for global technical / CMC activities across development and marketed products.
2. Support development and supply teams with aligned regulatory positions.
3. Oversee the content and assembly of all submission documents.
4. Maintain communication with health authorities.
5. Influence industry standards and health authorities’ policies.
6. Provide regulatory support for quality systems and ensure compliance with permits and licenses.
7. Stay current with regulatory knowledge, information, and best practices.
8. Collaborate with internal and external partners, including PDR, DRA, and PT, for effective execution.
9. Position Roche as a recognized industry leader with health authorities and peer groups.
10. Ensure external efforts facilitate pipeline development, marketing authorizations, and manufacturing excellence.
11. Support the implementation and execution of Pharma Quality Systems from a regulatory perspective.
12. Maintain consistency between regulatory permits/licenses and technical operations.
13. Strategically manage talent resourcing and development planning.
14. Provide training and resources on global guidelines and operational requirements.
15. Develop SMEs in regulatory strategy on key topics.
16. Optimize organizational structure for efficiency and effectiveness (New Ways of Working).
17. Align organizational goals with stakeholder organizations.
18. Manage budget and resource allocation.
19. Ensure effective communication within and outside the Regulatory team.
Who you are :
* PhD in a relevant technical field with 15+ years of experience in Regulatory, Quality, Process Development, or Manufacturing within the biopharmaceutical industry.
* Senior leadership experience in biotechnology or pharmaceuticals.
* Proven ability to lead in a complex, global, matrixed environment.
* Track record of elevating organizational performance.
* Strong leadership skills, including strategic alignment, motivating teams, and driving lean transformation.
* Excellent communication skills with diverse stakeholders.
* Ability to foster talent and build effective organizational structures.
* Experience contributing to and influencing leadership decisions.
* Successful change management experience, driving significant positive change efficiently.
Genentech is an equal opportunity employer. We promote and treat all employees and applicants based on merit, qualifications, and competence, and prohibit unlawful discrimination, including on the basis of protected veteran status and disabilities. If you need accommodations during the application process, please contact us using the provided form.
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