M.pharm Ram Mohan Kathuroju Rac

Vp-regulatory Affairs at Chartwell Pharmaceuticals

Ram Mohan Kathuroju, M.Pharm, RAC has over 20 years of experience in the pharmaceutical industry. Ram Mohan started their career at Gland Pharma Limited, where they led the Drug Regulatory Affairs department and prepared and filed several dossiers in emerging markets.

Ram Mohan then worked at Dr. Reddy's Laboratories as a Group Leader in International Regulatory Affairs, where they led a team responsible for preparing ANDAs and UK MAAs for solid oral dosage forms.

After that, they joined Dabur Research Foundation as a Manager in Regulatory Affairs, where they played a key role in the "new Generics team" by providing training on CFRs and ANDA guidances, and led the preparation of ANDAs and MAAs for Oncological Injectables in eCTD.

Ram Mohan then worked at Belcher Pharmaceuticals, Inc as a Manager in Regulatory Affairs, where they successfully established the regulatory team and led various regulatory submissions and compliance functions.

Ram Mohan continued their career at Belcher Pharmaceuticals, LLC as a Director in Regulatory Affairs before joining InvaGen Pharmaceuticals Inc., a Cipla Subsidiary, as Director-RA. In this role, they mentored and empowered the Regulatory Affairs Department and developed filing strategies for high-quality original ANDA applications.

Currently, they serve as the VP-Regulatory Affairs at Chartwell Pharmaceuticals, where they lead the regulatory function for various submissions, reviews change controls, and liaises with API vendors.

Throughout their career, Ram Mohan has demonstrated leadership, mentoring skills, and expertise in regulatory affairs, with a focus on achieving timely approvals and compliance with regulatory requirements.

Ram Mohan Kathuroju, M.Pharm, RAC has a Master of Pharmacy degree in Pharmaceutical Biotechnology from Andhra University. Ram Mohan is currently pursuing a Ph.D. in Pharmaceutical Technology, also from Andhra University. Additionally, Ram Mohan has obtained several certifications including a Professional Certificate in Corporate Finance from Columbia Business School in October 2019, a Professional Certificate in SOFT SKILLS from Rochester Institute of Technology in March 2019, and a Certification in General Course on Intellectual Property from the World Intellectual Property Organization (WIPO). Ram Mohan is also a Regulatory Affairs Certification (RAC-US) holder from the Regulatory Affairs Professionals Society (RAPS).

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Timeline

  • Vp-regulatory Affairs

    October, 2018 - present