Head of Technical Implementation

4 weeks ago

South San Francisco, California, United States Jobleads-US Full time
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. 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 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.
Develop and execute regulatory strategy
Support development and product supply teams with aligned regulatory positions
Direct content and assembly of all submissions
Provide regulatory support for quality systems
Remain current with regulatory knowledge, information, and best practices
Collaborate with internal and external partners and stakeholders, including PDR, DRA, and PT, for execution
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
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)
Establish and manage budget, allocate resources
Ensure effective communication within, to, and from Technical Regulatory
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.
Proven track record of leading organizations to a higher level of performance.
delivering short-term results while at the same time driving lean transformation within the organization.
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.
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