Arcus Biosciences, Inc. Hayward, California
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Senior Manager / Associate Director, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. The successful candidate will have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. Job Responsibilities: Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy. Author and review CMC modules of applications and amendments for submission, ensuring complete CMC content that meets current regional requirements. Author and review responses to health authority requests for information. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams for all CMC related issues. Coordinate regulatory section revision and lead adjudication meetings. Review IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and regulatory messaging. Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes. Develop excellent relationships with internal functional groups and contract manufacturing organizations to effectively influence the implementation of optimum regulatory strategies. Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes. Qualifications (including knowledge & skills): Bachelor's degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred. At least 4 years of experience in Regulatory Affairs in addition to at least 6 years (Senior Manager) or 8 years (Associate Director) in a related CMC discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle). Strong working knowledge of US and EU regulatory requirements as well as ICH guidelines (CMC) for biologics and small molecules. Experience in preparation of clinical trial applications for pharmaceutical or biologic products in the US, Canada, and/or Europe using eCTD format. Outstanding interpersonal and communication (written and verbal) skills are required. Demonstrated ability to work within a cross-functional matrix team environment. Highly organized, independent, self-motivated, and able to meet deadlines. Strong experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Prefer experience in use of a validated Regulatory Information Management system such as Veeva RIM or other Veeva module (Veeva Vault).