Regulatory Affairs CMC Animal Heath

3 weeks ago

Rahway, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities:
  • Well versed in performing CMC compliance activities including Gap Analysis and assessment for Annex 3 comparative table with reference EU Member States
  • Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports and Expert reports.
  • Experience in reviewing of CMC quality documents like Product development report, process validation, method validation, stability data, finished product specification as per guideline.
  • Knowledge about VICH guideline, USP, Ph. Eur requirements for veterinary products and guidance (not limited to QRD veterinary template, guideline on SPCs for antimicrobials, MRL etc.)
  • Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance.
  • Review of artworks / labelling, SmPC and pack insert.
  • Comparison of CPCs (Critical Pharmaceutical Characteristics), Prepare and submit a proposal of a harmonised SPC.
Requirements:
  • Bachelor's or master's degree required in science, engineering, or related field (advanced degree preferred).
  • Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields
  • Knowledge and hands on experience on Animal Health CMC.
  • Marketing authorization experience.
  • Proven Project Management Experience We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities.
  • Well versed in performing CMC compliance activities including Gap Analysis and assessment for Annex 3 comparative table with reference EU Member States
  • Manage execution / authoring and review of CMC documentation (Module 1, 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration.
  • Experience should be 5 years.

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