Anil Dudam
Senior Manager Regulatory Affairs Cmc @WuXi Chemistry
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WORK HISTORY
Senior Manager Regulatory Affairs Cmc @WuXi Chemistry
San Diego, CA, US
Author and review CMC sections (Module 2 and Module 3) of multiple IND, NDA/BLA and DMF regulatory submissions for a diverse range of modalities, including small molecules, synthetic oligonucleotides, peptides and antibody-drug conjugates. Develop and implement regulatory CMC strategies for small molecule drugs and biologics. Assesses and communicates CMC regulatory requirements to ensure all development activities comply with applicable regulations and guidelines. Serves as the regulatory CMC representative for assigned projects at Wuxi STA internal meetings as well as at meetings and communicates with clients. Performs quality control review to ensure compliance to submission standards throughout the product lifecycle and timely delivery of high qulaity regulatory submissions and services. Maintains knowledge of current applicable industry (GMP) and regulatory guidelines ( USP,ICH,FDA) and requirements. Developed and managed an in-house Regulatory Operations function to streamline publishing activities and enhance submission efficiency for the organization
EDUCATION
Kakatiya University
Bachelor of Pharmacy (B.Pharm.)
Sacred Heart University
Master of Science (MS), Chemistry
ABOUT ANIL DUDAM
I am a CMC Regulatory Affairs professional with over 12 plus years of industry experience, specializing in drafting CMC sections for Modules 2 and 3 of INDs, DMFs, NDAs, and BLAs. My expertise spans regulatory strategy, regulatory operations, and quality compliance, ensuring seamless regulatory submissions and approvals.Currently, I serve as Senior Manager, CMC Regulatory Affairs at WuXi STA, where I: Author and review CMC sections for global regulatory submissions Develop and implement regulatory CMC strategies Assess and communicate evolving regulatory requirements Serve as a CMC regulatory representative, liaising with cross-functional teams Conduct quality control reviews of submission documentsPreviously, as Scientist II, Analytical Sciences (CMC) at Gossamer Bio, I led analytical development for multiple NDA projects, ensuring the timely delivery of analytical data from CMOs and CROs. I also authored analytical CMC sections for INDs and NDAs, aligning with FDA, ICH, and USP regulatory standards.I bring a strong technical foundation in chemistry and pharmaceutical sciences, holding a Master’s in Chemistry from Sacred Heart University and a Pharmaceutical Sciences degree from Kakatiya University.I am known for my strategic mindset, regulatory acumen, and ability to drive compliance excellence while optimizing regulatory processes. Passionate about navigating the complexities of global regulations, I collaborate with teams to ensure successful regulatory outcomes.Let’s connect to discuss CMC regulatory affairs, regulatory operations, and pharmaceutical compliance strategies!
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