Kashiv BioSciences LLC

AGM-GRA (Regulatory Affairs)

Kashiv BioSciences LLC  •  United States (Onsite)  •  8 days ago
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Job Description

  • Lead/support emerging markets (and Japan, Canada, ANZ) filing for Biosimilars, NCEs &ANDAs,
  • Query responses, audit support, and lifecycle management.
  • Regulatory support for the filing of IND/CTA to various regulatory agencies.
  • Maintenance of IND/CTA through submission of protocol amendments, addition of investigators, EC approvals, SAE report submission, quarterly/annual Report, etc.

Interested Candidates Please share the resumes at anjali.joshi@kashivindia.com

Requirements

  • Education: Masters in biotechnology /Pharma- Regulatory Affairs/Pharmaceutical Biotechnology
  • Experience: 12-15 Years
  • Skills: Exposure in Emerging markets, Regulated Markets, Regulatory guidance, Dossier Preparation, Biosimilars and NCEs
Kashiv BioSciences LLC

About Kashiv BioSciences LLC

Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Industry
Chemicals & Materials
Company Size
201-500 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2011
Website
kashivbiosciences.com
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