SANGAMESH PURANIK

Head-Regulatory Affairs

PROFILE
A Pharma Professional with 21 Years of experience in various fields of Pharma, Food Quality and Regulatory Affairs. Expertise in Market Authorization Applications-Small molecules/Novel Biological/Biosimilars products, CT Applications, Food & Dietary Health Supplements, Controlled drug substances etc.

EDUCATION

1.PHD in Quality Assurance {Al-Ameen college of pharmacy, Rajiv Gandhi university of health sciences, Bangalore, Karnataka}
2.MBA {IGNOU}
3.PGDRA, PGDIPRL, PGDCR BII, CATALYST, NSLUI
4.M.PHARM PHARMACEUTICAL ANALYSIS 1999 {HKES College of Pharmacy, Rajiv Gandhi university of health sciences, Bangalore,}

WORK EXPERIENCE

Anthem Bioscience Pvt. Ltd - Head Regulatory Affairs 2015–2020

•In Depth understanding and Hands on Experience on
•Marketing authorization application (Novel biological, biosimilar and Pharma products) (Form 44, CTD dossier preparation)
•Preclinical, BA/BE & CT NOC (Phase I/II/III)
•Registration certificates and import licenses of Drugs (Pharma & Biologicals)
•Test License (Form 11), NOC for Form 29 & Export NOCs
•Import/Export of GMOs/LMOs and product for R&D to RCGM
•Manufacturing Licenses and various certificates (COOPs, FSC and GMP, SLSPP)
•Medical Device Registration (510K), CE marking Declaration of conformity
•Intellectual Property Rights
•Patents and Trademarks
•Compulsory Licensing, GATT, TRIPS, TRIMS, WTO, FSSA

MEMBERSHIPS
•Life member of APTI: KA/LM 554.
•Life member of In Pharm Association: 283-PM- 2009
•Voting member of RAPS USA. Reg No: 09458917
•Life member of AFSTI- Mumbai Chapter
•President of Association of Regulatory Affairs Professionals – New Delhi.

SKILLS
•Teaching, Coaching & Mentoring
•Communication & Interpersonal skills
•Detail oriented & Business Analysis
•Team Player & Team Leader

ENGAGEMENTS
•Founder and Program Director Drishti Institute of distance learning Bangalore since 2011.
•Founder and CEO Masanga Laboratories Pvt Limited.
•Founder and Director of Saskia Labs Pvt Limited.
•Founder and Director Thiagrow labs private limited.

INTERESTS
•Facilitate and Attend workshops
•Paper presentations
•Learning & Development
•Upskill with market trends of the industry
•Guest Speaker in Industry and Academic Institutes