Biotech Lab

2 weeks ago

Mumbai, Maharashtra, India Ipca Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Dear Candidate,

We are hiring the candidate for the below job profile

Department:

Advanced Biotech Lab (ABL)

Location:

Mumbai

Role:

Team member - ABL - RA

Key Responsibilities:

l Responsible for dossier authoring for regulatory filings

l Independent project responsibility in RA

l Responsible for cross functional coordination & support (R & D and Bio-manufacturing)

Key Activities:

l Regulatory dossier authoring and submissions

l Regulatory query responses and troubleshooting

l Assessment of change controls impacting Regulatory submissions

l Coordination and support cross-functional activities

l Document review (R & D and Bio-manufacturing)

l Presentation on updated regulatory guidelines and implementation across R & D and Bio-manufacturing

Functional Knowledge / Skills:

  • General
  • Specialized
  • Knowledge of Biosimilar data from R & D and Manufacturing
  • Scientific writing skill
  • Inter communication skill/CFT functions
  • Expertise in biosimilar R&D regulatory filings for regulated markets and semi-regulated markets (MHRA-UK, US FDA, EMA, Health Canada, RoW etc.)
  • Regulatory query response
  • Document review for regulatory submissions

Key Relationship:

  • QA Department
  • ADL
  • BDL
  • CDL
  • USP
  • DSP
  • DS and DP Manufacturing
  • QC
  • GMP-QA

Key Competencies:

  • Qualification

  • Essential

  • Desirable

  • Experience

  • Essential

  • Desirable

(Biotechnology or relevant)

4 - 10 years of experience in regulatory submissions of biosimilar products (preferable mAbs and peptides)

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