Meghan Brown's Work Experience
Executive Director, Regulatory Affairs CMC, Head of Regulatory Affairs CMC
Director Regulatory Affairs CMC Biologics
Head of Regulatory Affairs, Associate Director, Global Regulatory Affairs
Genzyme, a Sanofi Company
Manager, Global Regulatory Affairs CMC
Senior Manager, Regulatory Affairs
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Frequently Asked Questions about Meghan Brown
What company does Meghan Brown work for?
Meghan Brown works for Sarepta Therapeutics
What is Meghan Brown's role at Sarepta Therapeutics?
Meghan Brown is Executive Director, Regulatory Affairs CMC, Head of Regulatory Affairs CMC
Meghan Brown's phone (**) *** *** 381
What industry does Meghan Brown work in?
Meghan Brown works in the Biotechnology industry.
About Meghan Brown
💼 Past Experience
Meghan Brown, currently a Manager, Global Regulatory Affairs CMC at Genzyme, a Sanofi Company from January 2013 to July 2015 (2 years 7 months). Meghan Brown is responsible for preparing the global regulatory strategy to support submissions and health authorities inquires for development and commercial products, examples of submissions include; IND; CTA, new marketing applications; scaling up a manufacturing process, manufacturing site, analytical method; changes to release and stability specifications; drug substance (upstream and downstream) and drug product process changes. Meghan Brown also manages four regulatory affairs associate who are responsible for seven additional products including both clinical and commercial small molecule/biological. The primary FDA contact for two BLA applications and two IND applications is Meghan Brown's work with global health authorities, interactions with global health authorities including; leading CMC discussions at formal global health authority meetings for US FDA, EMA, China FDA and Health Canada and preparing correspondence for global health authorities for example; AVISA, TGA, and PMDA. Meghan Brown is also responsible for developing global regulatory strategies by applying ICH guidelines and country specific regulations for proposed and implemented manufacturing changes for marketed products by identifying priority submissions and obtaining global approvals. In support of this work, Meghan Brown also works with the mother company to develop regulatory strategies for product approvals and manufacturing changes for products. The regulatory CMC leader for the first biological product to be approved in China is Meghan Brown. Meghan Brown is also responsible for preparing the global regulatory submissions for clinical and commercial biological products in Common Technical Document (CTD) format or country specific formats as needed. In addition, Meghan Brown is also responsible for preparing FDA meeting requests and briefing documents and advising Subject Matter Expert (SME’s) on the product manufacturing teams. Meghan Brown is also responsible for preparing responses to health authority inquires and coordinating reviews with project team members. As a result of her responsibilities, Meghan Brown has played a significant role in the successful launches of two gene therapies into commercialization. Meghan Brown also has experience teaching assistant at Temple University, where she teaches undergraduate biology.
Meghan Brown's education and work readiness is based on her previous education that she obtained from Temple University in 2004 to 2008. Meghan Brown's education focused on biochemistry which she completed at Temple University in 2001. Meghan Brown's work readiness focuses on researching and writing academic papers. Meghan Brown has also been involved in conducting teaching and office work for her work at Temple University.Meghan Brown's previous education and work readiness provides her with the tools and experience she needs to achieve success in her future endeavors. With her education and experience in biochemistry, Meghan Brown has the knowledge and experience to look at research projects from a variety of angles and to develop work plans that are based on critical thinking and planning. Meghan Brown learned how to be a critical thinker through her education and experience in biochemistry. Meghan Brown is willing to take on any task that is set before her, and she is also able to work well in any environment. This makes Meghan Brown a competent and successful member of any team.Meghan Brown is passionate about her work and wants to help others achieve their goals. Meghan Brown is a hard worker who is always ahead of the curve. She is unwilling to let anything slow her down and is always looking to improve her work. Meghan Brown is a confident person who is always trying to make a positive impact in her work. Meghan Brown is a good member of any team and is a strong communicator. Meghan Brown is capable of working independently as well as as part of a team.
💡 Technical & Interpersonal Skills
Meghan Brown has experience in a variety of areas of regulatory Affairs, including product development, marketing and regulatory affairs for biological products. In her previous roles, Meghan has worked with organizations such as Genzyme, Novartis, and Sarepta Therapeutics. Meghan has aBackground in Chemistry and Biology, and has experience in a variety of Regulatory Affairs areas, including product development, marketing and regulatory affairs for biological products. Meghan is a senior director at a biotechnology company, and has been responsible for leading the CMC group for the company. Meghan also has experience in teaching and research, and is a member of the regulatory affairs team at a medical school.
In a nutshell
Extraversion (E), Sensing (S), Feeling (F), Judging (J)
2 year(s), 0 month(s)
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