Regulatory Affairs - Animal Health

Regulatory Affairs - Animal HealthLocation: Rahway, NJ - Onsite from day 1Pay Rate: $42/hrDuration: 11 MonthsWe are inviting applications for the role of CMC 2 Regulatory affairs.

Responsibilities include:Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member StatesManage 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 reportsExperience in reviewing of CMC quality documents like Product development report, process validation, method validation, stability data, finished product specification as per guidelineKnowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applicationsPh. 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 guidanceReview of artworks / labelling, SmPC and pack insertComparison of CPCs (Critical Pharmaceutical Characteristics), Prepare and submit a proposal of a harmonised SPCEvaluation and Assessment of change control and develop a plan with timeline to implement the sameKnowledge and experience on reviewing the DMF and assessment of Drug substance related changes, gap analysis and authoring of corresponding variation packagesHands on experience on authoring CMC documentation for worldwide marketing of Veterinary products for initial registration and life-cycle managementPlanning the project by understanding the client needs, managing project deliverables and providing solutions in real timeWork with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholdersDeliver all regulatory milestones as per agreed SLAs with clientsIdentify, communicate and escalate potential regulatory issues / risks and propose mitigationQualifications we seek in you!Experience should be 4 to 7 yearsBachelor'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 fieldsKnowledge and hands on experience on Animal Health CMCMarketing authorization experienceProven Project Management experience