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CMC 2 Regulatory affairs

2 months ago

Rahway, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
About the Company:

We are a leading company in the healthcare industry, dedicated to providing high-quality veterinary products to improve animal health.



Responsibilities:
  • Proficient in conducting CMC compliance activities, including Gap Analysis and assessment for Annex 3 comparative table with reference to EU Member States.
  • Manage the preparation and review of CMC documentation for various regulatory submissions and life cycle management processes.
  • Review CMC quality documents such as product development reports, process validation, stability data, and finished product specifications.
  • Familiarity with relevant regulatory guidelines such as VICH, USP, EU, and ICH guidelines.
  • Lead the development and implementation of regulatory strategies for veterinary products in compliance with global regulations.
  • Review and approve artworks, labeling, SmPC, and pack inserts for accuracy and compliance.
  • Prepare harmonized SPC proposals and evaluate change control processes.
  • Assess DMFs, drug substance changes, and author corresponding variation packages.
  • Hands-on experience in authoring CMC documentation for global marketing of veterinary products.
  • Collaborate with cross-functional teams to ensure timely project deliverables and stakeholder reporting.
  • Ensure compliance with regulatory milestones and manage potential issues or risks effectively.


Requirements:
  • Minimum 4-7 years of experience in regulatory affairs within the pharmaceutical or related industry.
  • Bachelor's or master's degree in science, engineering, or related field (advanced degree preferred).
  • Experience in Animal Health CMC and marketing authorization processes.
  • Demonstrated project management skills and ability to handle regulatory submissions efficiently.

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