Head of Pharma Technical Regulatory

The Position

In Pharma Technical Regulatory (PTR) we develop and maintain our licenses globally and influence Health Authorities in their thought processes to develop regulations.

In the role of 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, with a budget responsibility of approximately 100m CHF.

As a member of the PT leadership team, you will work collaboratively as part of a team to establish priorities and direction for the organization to meet its business needs and achieve the company’s long-range goals.

You will be accountable for the quality of all Regulatory Applications, including initial global Marketing Authorizations for Roche’s portfolio. You will be responsible for all interactions with global Health Authorities related to CMC aspects. You are expected to be a thought leader in the industry, helping to shape the regulatory environment and develop innovative concepts in support of PT’s mission.

Key responsibilities:

Working with and through PTR LT members, accountable for all global technical/CMC regulatory activities for all development and marketed products, including:

• Develop and execute regulatory strategy
• Support development and product supply teams with aligned regulatory positions
• Direct content and assembly of all submissions
• Communicate with health authorities
• Influence industry and health authorities
• Provide regulatory support for quality systems
• Remain current with regulatory knowledge, information, and best practices
• Maintain compliance with permits/licenses
• Collaborate with internal and external partners and stakeholders, including PDR, DRA, and PT, for execution
• Ensure that Roche is globally recognized as an industry leader with health authorities and industry peer groups
• Ensure external efforts return significant value in facilitating pipeline development, marketing authorizations, and excellence in manufacturing
• Provide technical regulatory support for implementation and execution of Pharma Quality System
• Drive maintenance of consistency between regulatory permits/licenses and technical operations
• Ensure strategic talent resourcing and aligned development planning
• Provide training and information resources related to global guidelines and operational requirements
• Foster development of SMEs in regulatory strategy related to key topics
• Ensure organizational structure facilitates efficient and effective achievement of accountabilities and goals (New Ways of Working)
• Ensure alignment of organizational goals with relevant stakeholder organizations
• Establish and manage budget, allocate resources
• Ensure effective communication within, to, and from Technical Regulatory

Who you are:

• PhD in a relevant technical area with 15+ years of experience in Regulatory, Quality, Process Development or Manufacturing in the biopharmaceutical industry.
• Senior leadership experience within the biotechnology or pharmaceutical industries.
• Relevant experience and the appropriate interpersonal skills to successfully perform in a complex, global, and highly matrixed environment.
• Proven track record of leading organizations to a higher level of performance.
• Key leadership attributes of this position include gaining alignment across multiple areas of functional expertise and cultures on strategy; engaging and motivating a diverse Leadership Team and technology-oriented workforce in the execution of that strategy; delivering short-term results while at the same time driving lean transformation within the organization.
• Ability to effectively communicate to a diverse set of stakeholders including business areas and regions, demonstrating strong customer focus.
• Strong ability to cultivate talent within the organization by providing the necessary structure and processes to enable the positioning of the best people at the right place at the right time.
• Expected to contribute to and influence decisions at the Pharma Technical Leadership Team level.
• Demonstrated track record in leadership of change management and a proven history of driving significant change in a short period of time in a positive and non-disruptive manner to the organization and the company’s values.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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