Associate Director/Director (Contractor), Regulatory Affairs Cmc, (Office Or Remote)

TheAssociate Director/Director (Contractor), Regulatory Affairs CMCwill 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.
NOTE: This is a 6 month full time contract through our approved payroll vendor.

Responsibilities

• Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus biologic 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.
• Coordinate regulatory section revision and lead adjudication meetings.
• Seek internal expert advice and technical support as required for strategies and submissions.
• Contribute to and review CMC content of original INDs, IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and strategic regulatory messaging.
• Lead annual Investigator's Brochure updates for Arcus clinical programs
• Track and report on external Regulatory CMC guidance and pharmacopeia changes
• Assist in developing and maintaining Regulatory CMC risk assessments

Qualifications

• Bachelor's degree in life sciences in chemistry, molecular biology, immunology, or similar major is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred.
• At least 7 years' experience in a biologics CMC function (Process Development, Analytical, Manufacturing, QC, or QA, etc.) in the biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle).
• Highly preferable to have knowledge of monoclonal antibody CMC-related development and greater than 3 year of Regulatory CMC experience (3 years AD level & min 5 years for Director).
• 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).

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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