Sr. Manager, Regulatory Affairs CMC (Office Or Remote)

Senior Manager, Regulatory Affairs CMC

Summary:

The Senior Manager, Regulatory Affairs CMC will 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.

Responsibilities:

• Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus small molecule and/or 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 scientific discipline, Regulatory Science or similar major and/or RAC certification is preferred.

• At least 4 years of experience in Regulatory Affairs CMC, in addition to at least 5 years experience in a related CMC discipline (Process Development, Analytical, Manufacturing, QC, or QA, etc.) in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP, CMC-related development, phases of product lifecycle).

• Strong experience in the developing regulatory CMC strategy, preparation and submission of global CTA filings and respective amendments of critical impact on the successful execution of global trials.

• Ability to work on issues where analysis of situations or data requires conceptual thinking and in-depth knowledge of organizational objectives, or evolving strategic direction.

• Demonstrated ability to advise team on moderately complex regulatory matters.

• 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).

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $160,000 - $190,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.

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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