RA officer

2 weeks ago


Mumbai, Maharashtra, India Chemill Pharma Ltd. Full time ₹ 4,00,000 - ₹ 8,00,000 per year
  1. Role is for individual contributor + working independently with minimum

supervision.

  1. Handson experience of CTD Dossiers & HA Queries– compilation/review/

submission.

  1. Preparation of Pack Insert (PI)/ PIL

  2. Review/ approval of Artworks.

  3. Peer review of technical documents

  4. Strong follow up with external manufacturer so as to get submission

docs/ samples on time through email/ phone call/ Teams meetings / site

visits as we have a CMO (Contract Manufacturing Organization) business

model.

  1. Coordination with internal stakeholders.

  2. Well versed with ICH guidelines

  3. Life cycle management – Variation/ Renewals etc.

10.Must have worked for minimum 2 territories Hong Kong/ Singapore/

Africa/ FWA/LATAM/GCC/Russia-CIS/ China etc.

11.Added advantage, if worked for EU/ US/TGA/SA/CA/ China/ PICs etc. +

tender support.


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