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Regulatory Affairs - Animal HealthAA2IT • Rahway, NJ, United States
Regulatory Affairs - Animal Health

Regulatory Affairs - Animal Health

AA2IT • Rahway, NJ, United States
1 day ago
Salary
$42.00 hourly
Job type
  • Full-time
Job description

Regulatory Affairs - Animal Health

Location: Rahway, NJ - Onsite from day 1

Pay Rate: $42/hr

Duration: 11 Months

We 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 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
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Regulatory Affairs - Animal Health • Rahway, NJ, United States

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