| Contract Position with a Global Client | CMC Manager | Rahway, NJ(Onsite) at Rahway, New Jersey, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=584212&uid= From: Gauresh Gidwani, VBeyond Corporation [email protected] Reply to: [email protected] Role: CMC Manager Location: Rahway, NJ(Onsite) Type: Contract Job Description 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. Qualifications Experience should be 4 to 7 years Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related field Knowledge and hands on experience on Animal Health CMC Marketing authorization experience. Regards, Gauresh VBeyond E-mail ID: [email protected] Keywords: Idaho New Jersey http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=584212&uid= |
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| 11:53 PM 29-Aug-23 |