We currently have an opportunity for a Regulatory Program Director to join our global Pharma Technical Regulatory Biologics Marketed team.
Accountable for the development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.
Accountable for submissions of high quality CMC regulatory documents to health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
Effective management of regulatory changes throughout the product life cycle. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required.
Coordinating and/or leading health authority interactions for assigned projects; representing Technical Regulatory at multidisciplinary meetings with health authorities.
Representation of PTR on other cross-functional teams, such as Technical Development Teams (TDTs), Technical Product Teams (TPTs) and Regulatory Affairs Functional Teams (RAFTs).
Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
If applicable, leading a Technical Regulatory Team (TRT) of one or several technical regulatory professionals (depending on complexity of the program), which includes the ability to effectively delegate to team members and compile the resource needs for centralized planning.
Contribute to driving efficiency by assertively simplifying, taking risk and cutting out waste.
Must have a Bachelor's degree - preferably in a scientific field; an advanced degree is a plus.
A minimum of 12 years work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory or related experience.
A regulatory professional with a depth of technical experience and knowledge and the ability to manage complex issues with efficiency.
Experience in CMC regulatory considerations for biologics is preferred; other modalities including small molecules, device/combination products, etc. as well as Marketed Products are an advantage.
You should bring experience in technical (CMC) development, sound knowledge of global regulations and successful management of complex regulatory submissions. Direct interaction with Health Authorities is preferred.
Strong leader who is an agile strategic thinker with exceptional communication skills.
Possesses the ability to work effectively both within a team environment and independently.
You should be able to influence teams and functions in defining global technical regulatory strategies.
You are comfortable with taking risks, experimentation and ambiguity
Please note the positions can be located in Hillsboro, OR, as well as South San Francisco, Vacaville or Oceanside CA. *Flexible work arrangements and remote work from a US-based location outside of commuting distance from a Genentech location, will be considered
Support Genentech's mission of advancing and boldly championing diversity, equity, and inclusion
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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