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Dompé farmaceutici S.p.A.
Oakland, CA, United States
Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: We seek enthusiastic, resilient professionals to join Dompé’s US regulatory affairs department.The candidate reports to the Global Regulatory Affairs Senior Director and will play an important role within the Reg
Job Source: Dompé farmaceutici S.p.A.Abdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to s
Job Source: Abdera TherapeuticsAbdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes
Job Source: Abdera TherapeuticsAlumis Inc.
South San Francisco, CA, United States
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motiv
Job Source: Alumis Inc.BioSpace, Inc.
South San Francisco, CA, United States
Job Details Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an except
Job Source: BioSpace, Inc.Maze Therapeutics
South San Francisco, CA, United States
The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: Maze TherapeuticsPulmonx Corporation
Redwood City, CA, United States
The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below. Support Product Development & Registration: Provides strategic input and technical g
Job Source: Pulmonx CorporationAlumis Inc
South San Francisco, CA, United States
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motiv
Job Source: Alumis IncSouth San Francisco, CA, United States
The Position 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 $150,000 min 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.
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Email Alert for Regulatory Program Director jobs in South San Francisco, CA, United States
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