CMC 2 Regulatory affairs - Katalyst Healthcares & Life Sciences
Rahway, NJ 07065
About the Job
Responsibilities:
Requirements:
- 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.
Requirements:
- 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
Source : Katalyst Healthcares & Life Sciences