Manager, Regulatory Affairs CMC

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Job description

Position Summary:

AnaptysBio is seeking a Manager, Regulatory Affairs CMC to assist in the development of our monoclonal antibody biologic products. The Manager Regulatory Affairs CMC will work closely with the Sr. Director, Regulatory Affairs CMC and the CMC and QA groups on product development of drug substance and drug product, as well as control of the product and process. You will share your regulatory knowledge and insights that impact product and policy development by interpreting policy and industry trends, advising on regulatory health authority interactions, and sharing regulatory lessons learned in order to help users navigate policy issues and minimize regulatory risks.

Essential Functions:

• Work closely with the Sr. Director, Regulatory Affairs CMC and the CMC and QA groups in the development of biologic products.
• Author technical information in regulatory dossiers, such as INDs, IMPDs, and BLAs/MAAs.
• Provide regulatory knowledge and strategic insight to the product development process.
• Provide interpretation of applicable FDA/EMA/ICH/Global regulations to ensure compliant CMC communications with health authorities.
• Perform regulatory compliance assessment with respect to filing requirements for assigned projects throughout development.
• Prepare CMC content meeting data and documentation requirements for regulatory submissions and compile/review this content for conformance with established requirements.
• Support interaction with FDA and other health authorities regarding CMC matters.
• Ensure project team colleagues, line management, and key stakeholders are apprised of CMC risks that may impact regulatory success.
• Stay abreast of current and evolving regulatory CMC requirements, applying this knowledge to assigned projects, and sharing knowledge and experience with others to support their development.

Responsibilities:

• Support CMC regulatory strategy in various stages of biologic product development, including assessing regulatory risks and opportunities and pathways for aggressive and efficient development timelines.
• Responsible for preparing and reviewing technically complex Regulatory CMC submissions. Requires extensive interaction with departments within and outside of CMC for preparing regulatory documents while meeting aggressive timelines.
• Ensure regulatory submissions are in line with regulatory requirements and company policies and procedures. Ensure filings are completed in a timely manner, and that sound scientific justification is employed in CMC regulatory strategy.

Knowledge Requirements:

• Understanding of scientific principles and regulatory CMC requirements relevant to biologic development and registration.
• An understanding of the regulatory sciences.
• Able to deal with issues of critical importance, provide regulatory CMC advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of biologic drug substances and drug products.
• Exercises good judgement in elevating and communicating actual or potential regulatory CMC risks to teams and line management.
• Demonstrated problem-solving ability, flexibility and teamwork.
• Excellent written and oral communication skills required.

Work Environment:

• Position may require occasional evening and/or weekend commitment.
• Position may require domestic and international travel.

Requirements

Education & Experience:

• Requires a BS degree in a relevant discipline. An advanced degree is desirable.
• At least 5 years of relevant experience in Regulatory Affairs with a focus on CMC.
• Ability to provide strategic regulatory CMC guidance to teams.
• Must have experience with authoring and thoroughly reviewing regulatory/ quality CMC documentation for accuracy and conformance to regulatory/quality requirements.
• The role requires a self-motivated and independent team member with demonstrated capabilities in Regulatory Affairs, development strategy, biologics manufacturing and control, and preparation of regulatory submissions.
• Experience in interacting with regulatory health authorities is a plus.
• Experience with monoclonal antibody biologic products is a plus.

This is an office based position in San Diego and not eligible for 100% remote work.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.