Lenh Mong

Executive Director, Regulatory Affairs @ Annexon Biosciences

About

Experienced regulatory affairs professional with a strong legal and engineering background and a proven ability to lead cross-functional teams through all phases of drug development and due diligence. Adept at navigating complex regulatory landscapes and delivering strategic guidance in fast-paced, global environments. Known for clinical insight, analytical rigor, and regulatory innovation. Recognized for successfully driving multiple approvals and managing high-stakes FDA interactions.

Country

City

United States

Industry

Pharmaceuticals

Skill

Global Drug Development, EMA, Global Regulatory Affairs, Regulatory Affairs, Regulatory Strategy, Drug Development, Regulatory Requirements, Regulatory Submissions, Regulatory Compliance, Global Regulatory Compliance, Biologics License Application, Rare Diseases, Due Diligence, Regulatory Guidelines, Staffing Plans, Inspection Readiness, Product Launch Planning, Product Launch, Fixed Dose Combination Products, Combination product

Experience

Executive Director, Regulatory Affairs

Annexon Biosciences

2025-12 - Present · 10 mos

Southern California

Ophthalmology Therapeutic Head to provide regulatory leadership and strategic direction in support of the development, registration, and life-cycle management of Annexon products, and to advance a late-stage first-in-kind anti-C1q therapeutic agent to treat complement-mediated neurodegenerative ophthalmic diseases.

Senior Director, Regulatory Affairs

Prothena Corporation

2022-1 - 2025-8 · 3 yrs 8 mos

Southern California

Built out and led US Regulatory Clinical Strategy and Advertising & Promotion, and was Interim Head of Global Regulatory CMC across all programs (monoclonal antibodies and vaccines) to treat neurodegenerative and rare diseases. • Successfully filed three INDs within two years of which two were in parallel and obtained FTDs for 2 programs. • Led BLA preparation and agency interactions and provided regulatory strategic input for launch readiness activities as well as Medical (MRC) and promotional (CRC/MRL) reviews.

Director, Global Regulatory Affairs

AbbVie

2010-4 - 2022-1 · 11 yrs 10 mos

Irvine, California, United States

Over a decade of increasing roles and responsibilities at AbbVie via multiple acquisitions (previously Forest Laboratories, Actavis and Allergan) leading >15 CNS/neuroscience, Women’s Health and respiratory products. • Collaborated with cross-functional and global teams in proposing and executing strategic regulatory strategy for global drug development. • Managed global regulatory health authorities interactions and preparation of global marketing applications. Successfully filed a pediatric sNDA and three NDAs with significant clinical and CMC challenges. • US Regulatory Lead for multiple fixed dose combination respiratory products; developed regulatory strategic plan, and pediatric study plan for these programs. • Provided strategic and tactical regulatory due diligence assessments for potential in-licensing/acquisition of oncology, respiratory, dermatology and immunology products.

Associate Attorney

Cooper & Dunham, LLP (now Amster Rothstein & Ebenstein LLP)

2008-5 - 2009-9 · 1 yr 5 mos

New York, New York

Managed U.S. and global patent prosecution for siRNA, ribozymes, antisense oligonucleotides, antibodies, small molecules and diagnostic assays.

Associate (Level II to III) to Associate Manager, Regulatory Affairs

Regeneron

2002-7 - 2008-4 · 5 yrs 10 mos

Tarrytown, New York

• Prepared and obtained the first BLA approval for Regeneron for a rare disease and obtained FTD and orphan drug designation. Managed submissions of INDs to FDA, CTA to Health Canada and CTA/IMPD to EMA. • Facilitated multidisciplinary team discussions relating to issues associated with process scale-up, purification processes, analytical testing, cell culture media, stability, viral clearance, and biocomparability of products manufactured in a new manufacturing facility.