Vikas Jawalkar
Regulatory Affairs Professional | Biologics
- Role
- Director at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Vikas Jawalkar
With over 21 years of biotech industry experience, I am a seasoned regulatory professional and a biosimilars expert. My core competencies include developing and executing global CMC regulatory strategies, program management, alliance management, dossier writing and compilation, and face-to-face interactions with health authorities in regulated and emerging markets. I have a strong scientific background in R&D and a proven track record of obtaining registrations for complex biologics and insulins in various regions. I am passionate about delivering innovative and affordable biologics to patients and advancing the biosimilar industry. I am also recognized as a great manager and a collaborative leader who can influence key stakeholders, motivate and engage talent, and ensure business sustainability in a highly demanding and dynamic environment.
Experience
Director
Aug 2024 — Present · Bengaluru, IN
o Devise CMC regulatory strategies for novel biologics and synthetics both for primaryregistration and life cycle managemento Member of CMC leadership team to device functional ways of working and enablingprocesses to minimize redundancies and increase efficiencyo Develop strategies to accelerate access of medicines in international market through globalsimultaneous submission strategies
Education
Sri Krishnadevaraya University
Bachelor's degree, Microbiology
Sri Krishnadevaraya University
M.Sc, Microbiology
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