CMC 2 Regulatory Affairs

6 days ago

Short Hills, United States Varite Full time

Pay rate range: $40-43/hr.

Job Title: CMC 2 Regulatory affairs Location: Rahway, NJ - Onsite

Responsibilities: • 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. • Proven Project Management experience. #J-18808-Ljbffr

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