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 docu... more details
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.
