The Opportunity: This Job is an Individual Contributor position. In the position of Regulatory Program Director in Roche / Genentech Pharma Technical Regulatory (PTR), you will be accountable for Health Authority interactions pertaining to CMC Information (i.e.: CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and pre-submission meetings with global Health Authorities, partners and industry experts. You will be responsible for the submission of high-quality CMC regulatory documents to health authorities globally according to current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies. Accountable for the compliance and accuracy of the data in regulatory documents and in regulatory information management systems. Actively contribute to the success of technical regulatory team outcomes and to the timely regulatory approval of Roche products. Ensuring cross-functional PTR deliverables are completed compliantly, accurately, thoroughly and in a high quality and timely manner. Contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement. Support departmental business processes to document and improve best practices and work efficiency. Understands the structure, key roles and responsibilities of local and international regulators; understands global health authority regulations and ICH guidelines. Drive for faster access through optimal regulatory pathways, reliance and convergence Manage timely responses to Health Authority questions received from major/global regulators Ensure excellence in regulatory compliance throughout product lifecycle and support cross-functional compliance processes to maintain right to operate Who you are: Bachelor’s Degree in life science disciplines. Post Graduate Degree is a plus 10 or more years CMC experience with at least 5 years in large molecule (biologics) CMC Regulatory is required Cross-functional team leadership experience is desired Proven knowledge of relevant global Health Authority guidelines and experience in interacting with health authorities Track record in developing regulatory strategies and scenario planning with robust regulatory risk assessment Technical understanding of drug substance, product manufacturing, critical quality attributes, control system, process changes, and comparability in large molecule (biologics) is required Knowledge of drug development, commercialization process, supply chain complexity, product lifecycle management, and Pharmaceutical Quality Systems Ability to work with an agile mindset and to drive for continuous improvement Relocation is not available for this role. The expected salary range for this position based on the primary location of California is $150,000min and $250,000 max of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. Who We Are 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. The next step is yours. To apply today, click on the "Apply for this job" 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. If you are in need of an accommodation due to a disability to assist with submitting your application or at any point during the hiring process, please email US.accommodation@roche.com.