Location
Jersey City, NJ | United States
Job description
Job Title: CMC 2 - Merck Animal Health
The pay rate is $70- $78
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.
? Assessment of change control and develop a plan with timeline to implement the same.
? 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.
? Proven Project Management experience
Location:
? US
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