Network Architect

3 weeks ago

Milwaukee, United States Crescens Full time

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:

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

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