Martin Mao

Director, Regulatory Affairs @ AstraZeneca

About

o 12 + years of regulatory affairs experience - Represent regulatory in cross-functional team - Seasoned project management skills; - Regional experience of US, Canada, Japan and China - Hands-on IND, CTA, NDA submission experience;

Country

United States

City

Washington DC-Baltimore Area

Industry

Pharmaceuticals

Skill

IND, Regulatory Affairs, Regulatory Submissions, Vaccines, FDA, CMC, Annual Reports, IMPD, Project Management, RA training, Regulatory Intelligence, Biotechnology, Molecular Biology, Pharmaceutical Engineering, FDA Communication, cGMP, Regulatory Projects

Experience

Director, Regulatory Affairs

AstraZeneca

2020-12 - Present · 5 yrs 10 mos

Associate Direcor, Regulatory Affairs

AstraZeneca

2019-1 - 2020-12 · 2 yrs

Gaithersburg, Maryland

Manager, Regulatory Affairs

AstraZeneca

2016-11 - 2018-12 · 2 yrs 2 mos

Gaithersburg, Maryland

Manager, Regulatory Affairs

Abbott

2014-8 - 2016-11 · 2 yrs 4 mos

Illinois

Regulatory Affairs Project Manager to support M&P and Mfg capacity program, manage post approval changes strategy, product life cycle management, align with over 40 affiliates on strategy and execution plan, communicate and influence both cross-functional team and sub team to fulfill business needs and achieve above average performance.

Regulatory Affairs Manager (2013-2014), Associate (2010-2013)

American Oriental Bioengineering Inc.

2010-6 - 2014-7 · 4 yrs 2 mos

New Jersey

Regulatory knowledge of ICH, US, EU, JP and China regulatory requirements. Led regulatory sub-team with operational leadership. Successfully develop regulatory strategy for product development, authored and reviewed regulatory documents - INDs/CTAs/NDAs, contributed to clinical study documents, move product development from preclinical to Phase III. Made contribution to clinical development and formal meeting with FDA.