Regulatory Consultant - Biosimilars CMC

Position – Consultant

Company Information

We are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Biopharmaceutical and Pharmaceutical Industry in India and internationally. We have a young and committed team of GMP and Regulatory Experts. We are inviting applications for the role of Consultant and are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm.

Role & Responsibilities

The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following:

• Ownership for assigned regulatory projects including regulatory strategy, dossier writing, submissions, approval tracking, query resolution (EU, UK, AUS)
• Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs
• Providing strategic input to the Management and Partners on regulatory projects
• Keep abreast of new developments in regulations across all critical health authorities

Experience & Qualifications

Techn

• Total: 10-15 years of Regulatory experience with 2-5 years in biosimilars/biologics (vaccines, insulin, mAbs) industry preferred
• Academic Qualifications: M.Pharm, M.Tech, M.Sc. in Microbiology, Biotechnology or Life Sciences background
• Must have hands-on experience in authoring CTD Module 3 sections independently without much guidance
• 2–3 years EU regulatory experience (National/DCP/MRP/Centralized procedures experience is preferred)
• Post-approval lifecycle management experience
• Strong English communication skills

Mail us your CV at info@metinapharmconsulting.com