Regulatory Affairs CMC Animal Heath - Rahway, United States - Katalyst Healthcares and Life Sciences

Description

• 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.

• 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.