Manager, Regulatory Affairs

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Job description

Position Summary:

AnaptysBio is seeking a Manager, Regulatory Affairs to assist in the development of our monoclonal antibody biologic products. The Manager Regulatory Affairs will work closely with the Sr. Director, Regulatory Affairs supporting the development and implementation of regulatory strategies for pipeline programs. You will share your regulatory knowledge and insights that impact product and policy development by interpreting policy and industry trends, advising on agency interactions, and sharing regulatory lessons learned in order to help users navigate policy issues and minimize regulatory risks. Additionally, the position will manage the regulatory operations for all development programs as directed by your supervisor.

Essential Functions:

• Work closely with the Sr. Director, Regulatory Affairs as well as the Clinical, Nonclinical, and Regulatory Operations groups.
• Provide regulatory knowledge and strategic insight to the product development process.
• Provide interpretation of applicable FDA/EMA/ICH/Global regulations to ensure compliant communications with health authorities.
• Perform regulatory compliance assessment with respect to filing requirements for assigned projects throughout development.
• Prepare 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.
• Ensure project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success.
• Stay abreast of current and evolving regulatory requirements, applying this knowledge to assigned projects, and sharing knowledge and experience with others to support their development.

Responsibilities:

• Support the development, implementation and maintenance of regulatory strategies and activities for AnaptysBio's pipeline programs.
• Review protocols, reports and summary documents (clinical, pharmacology & toxicology) for adherence to regulatory guidelines, strategies, and commitments.
• Manage the assembly, support the review and submission of regulatory documentation such as INDs, CTAs, Health Authority interactions, etc. ensuring consistency/completeness/adherence to standards for all regulatory submissions.
• Ensure the quality, content and format of regulatory submissions and for communication and teamwork with project team members.
• Keep abreast of all pertinent laws, regulations and guidance; develop aligned recommendations for regional regulatory strategies and implementation activities and share insights that impact product and policy development on a global level.
• Support the development and implementation of regulatory affairs practices and policies in compliance with quality systems, and to assure adherence to global and regional requirements, and SOPs.
• Support the implementation of departmental Standard Operating Procedures (SOPs) to ensure compliance with applicable domestic and foreign regulations and industry guidance (cGMP, GCP, GLP, etc).
• The role requires a self-motivated and independent team member with demonstrated capabilities in Regulatory Affairs, development strategy, and preparation of regulatory submissions.

Knowledge Requirements:

• Understanding of scientific principles and regulatory requirements relevant to biologic development and registration.
• A scientific and clinical understanding of the regulatory sciences.
• Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Exercises good judgement in elevating and communicating actual or potential regulatory 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 or applicable experience in related areas of drug and biologic development.
• Ability to provide strategic regulatory guidance to teams.
• Must have experience with authoring and thoroughly reviewing regulatory documentation for accuracy and conformance to regulatory requirements.

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.