Sibel Boreham

Professional Overview

Sibel Boreham is an experienced Director of Regulatory Affairs with a strong background in the pharmaceutical and biotechnology industries. She specializes in navigating complex regulatory landscapes, ensuring compliance, and driving strategic regulatory initiatives to support the development and commercialization of innovative therapies.

Experience Summary

Current Role

Sibel currently serves as the Director of Regulatory Affairs at Annexon Biosciences, a clinical-stage biopharmaceutical company focused on novel therapies for autoimmune and neurodegenerative diseases. In this role, she is responsible for overseeing all regulatory activities, including the preparation and submission of regulatory filings, liaising with governmental authorities, and providing strategic guidance to cross-functional teams to ensure successful regulatory outcomes.

Career Progression

Prior to her current role, Sibel held the position of Director of Regulatory Affairs at Zogenix, Inc., where she played a pivotal role in the regulatory approval and launch of a rare disease treatment. Before that, she worked as a Regulatory Affairs Consultant at Intrinsik Corp., providing specialized expertise to pharmaceutical and biotechnology clients. Sibel's previous roles also include serving as the Director of Regulatory Affairs at IMV Inc. and NoNO Inc., where she demonstrated her ability to navigate complex regulatory environments and drive the successful progression of clinical programs.

Academic Background

Sibel holds a Master's degree in Pharmaceutical Sciences from the University of Toronto, where she specialized in regulatory affairs and clinical development. Her strong academic credentials and continuous professional development ensure that she remains at the forefront of regulatory best practices and industry trends.

Areas of Expertise

• Regulatory strategy and compliance

• Preparation and submission of regulatory filings (INDs, NDAs, MAAs)

• Liaison with regulatory authorities (FDA, EMA, Health Canada)

• Clinical development program oversight

• Cross-functional collaboration and stakeholder management

• Regulatory risk assessment and mitigation

Professional Impact

Throughout her career, Sibel has demonstrated a proven track record of driving successful regulatory outcomes. She has played a pivotal role in the approval and launch of several novel therapies, contributing to the advancement of patient care and improving access to life-changing treatments. Sibel's industry expertise, strategic thinking, and collaborative approach have earned her a reputation as a trusted regulatory affairs leader.

Conclusion

Sibel Boreham's extensive experience, combined with her deep regulatory expertise and commitment to innovation, makes her a valuable asset to the pharmaceutical and biotechnology sectors. As the Director of Regulatory Affairs at Annexon Biosciences, she continues to drive regulatory excellence and contribute to the development of transformative therapies.