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People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
The following opportunity exists in our South San Francisco, CA headquarters:
[Associate Program Director, Regulatory Program Management]
In this key strategic role within the I2ON (immunology, infectious disease, ophthalmology, neuroscience) Genentech Regulatory Program Management team you will formulate US and global regulatory strategies drawing on your own expertise and the resources of the global Roche regulatory network to drive product development from early development to post-marketing. You will take the lead for assigned projects and represent PDR to cross-functional teams and groups and serve as the principal interface with health authorities, developing the strategies for, managing, and executing these interactions.
Genentech, a member of the Roche group, has one of the richest and most diverse pipelines in the industry. The entrepreneurial spirit and inventiveness of our founders still defines our culture; a culture that encourages innovation and bold steps as vital partners to rigorous science. As you set off on the next leg of your regulatory career journey, explore Roche. Go ahead. Make a change. Make a difference.
Primary Duties And Responsibilities:
Plays a key role in creating innovative long-range strategies to expedite development of our projects in immunology, infectious disease, ophthalmology, or neuroscience therapeutic areas from entry into man through lifecycle management. Although the therapeutic area may evolve over time, currently, this position is expected to be the regulatory leader for two early development asthma projects.
Develops regulatory strategies with global cross functional clinical, non-clinical and business teams. Provides project teams with leadership regarding regulatory authority interactions.
As the US regulatory subject matter expert, leads the US Regulatory strategy as a member of a global Regulatory Affairs Functional Team (RAFT) for assigned development projects. Depending on your project assignment, you will also serve as the primary regulatory lead on one or more regional or global projects at any one point in time and be the regulatory read of the RAFT.
Acts as primary liaison and manages a professional relationship between the FDA and project teams for assigned projects.
Responsible for on time and quality regulatory submissions for INDs and BLAs/NDAs to the FDA.
Collaborates with the Canadian regulatory affiliate to develop and manage regulatory strategy and submissions to Health Canada for assigned projects.
Briefs regulatory management
Mentors and coaches junior regulatory professionals.
Stays abreast of internal and external developments, trends and other dynamics relevant to the work of Product Development and Regulatory to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects.
Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.
Average of 5 or more years’ relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing. Experience participating in global product development teams is preferred. Experience in development of products to treat respiratory diseases, such as asthma, a plus.
Experience as a regulatory contributor for global original IND/NDA/BLA filings in the US is preferred.
Broad understanding of US FDA regulations, processes and issues in drug/biologics development. Includes in-depth knowledge of GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
Previous experience working in a matrix management environment.
A Job with Benefits Beyond the Benefits
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.
Internal Number: 201901-101350
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.