Pankaj Chaudhari
Head - Global Regulatory Affairs (Biosimilar) at Abbott
- Role
- Head - Global Regulatory Affairs (Biosimilar) at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Pankaj Chaudhari
Innovative and accomplished professional with more than 15 years experience in Business…
Experience
Head - Global Regulatory Affairs (Biosimilar)
Sep 2024 — Present · Mumbai, IN
Lead and Manage global regulatory strategy and execution for Biosimilar development programs, ensuring timely and compliant submissions across key markets.2. Act as the regulatory point of contact for internal and external stakeholders 3. Anticipate regulatory risks and proactively mitigate them through strategic planning and stakeholder engagement 4. Ensure alignment with regional regulatory requirements and evolving guidelines5. Represent regulatory strategy scientific advice from regulatory agencies6 Collaborate cross-functionally with Clinical, CMC, PV and commercial teams to align regulatory deliverables7. Mentoring team for regulatory challenges and oversights of timelines and risks, encourage high standards in regulatory writing and strategy development8. Ensure all activities meet regulatory requirements and internal SOPs, reducing risk and ensuring successful submissions.
Education
KTHM College Cidco, Nasik
HSC, Biology, Maths, Chemistry, Physics, English
1999 — 2001
D. D. Bytco Boys Highschool
SSC, High School/Secondary Certificate Programs
1994 — 1999
UDCT Mumbai
MTech Bioprocess Technology, Chromatography, Downstream Processing, Genetic Engg, Plant Tissue Culture, Bioconversion
2005 — 2007
NDMVP'S College Of Pharmacy
BPharmacy, Pharmaceutics, Pharmacology, Pharma Engg., Pharma Marketing, Biochemistry, Med. Chemistry,
2001 — 2005
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