CMC 2 Regulatory affairs / Animal Health Care


On Site
Contract - W2
Contract - Independent
Contract - 11+ mo(s)


Please refer to job description

Job Details

Job Title: CMC 2 Regulatory affairs / Animal Health Care
Location: Remote
Hire Type: 6+ Month Contract (Extendable)

" Well versed in performing CMC compliance activities including Gap Analysis; 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 on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications.
" 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.
" Evaluation and Assessment of change control and develop a plan with timeline to implement the same.
" Knowledge and experience on reviewing the DMF and assessment of Drug substance related changes, gap analysis and authoring of corresponding variation packages.
" Hands on experience on authoring CMC documentation for worldwide marketing of Veterinary products for initial registration and life-cycle management.
" Planning the project by understanding the client needs, managing project deliverables and providing solutions in real time.
" Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders
" Deliver all regulatory milestones as per agreed SLAs with clients
" Identify, communicate and escalate potential regulatory issues / risks and propose mitigation.

Qualifications we seek in you!
" Experience should be 4 to 7 years
" 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.
Prashant Singh
Sr. Account Manager - Enterprise Business
Net2Source Inc.
Direct # | Board # Ext. 509 | Fax:
Office: 270 Davidson Ave, Suite 704, Somerset, NJ 08873

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