Provide Information and Regulatory Support to International RA team members for Product Registrations, Renewals, Launches, etc. / To provide support as needed, information to all global regions on all US products across the Company subsidiaries so that regions can file products with the data necessary for their submissions.
• Responsible for providing Regulatory Affairs support to International RA teams for product registrations, renewals to global markets for pharmaceuticals, medical devices and skin care products.
• The incumbent will provide support and applications for all requested documents (certificates/letters), search and retrieve product labeling & b11 needed support documentation.
• With the oversight of Regulatory leadership, the Incumbent will prepare and obtain:
-Letter of Authorizations/Letter of Declaration/Power of Attorney letters Certificate of Free Sale from State of NJ/ CPP from Federal Agency ( FDA)
• Notarized, Legalized, or Apostilted Regulatory Documents ill also be working on:
- Technical Inquiries and coordination (including Manufacturing, process, raw materials, technical files)
- Search and retrieve documents from RA system and tools and provide links to the international requesters (Sharepoint, Clinops, liquent /Insight viewer) where information can be found. Work with other International Support groups (Operations, QA, btc.) to provide assistance to regions.
SCOPE OF POSITION
• IUS Regulatory Support for all regions on US products
• For on-going Project Management support - provide budgets and updates as necessary to Senior Management.
Internal R&D, Supply Chain, and Business functional groups to support R&D Development projects as well as expand already approved products.
Regional functional groups (mainly Regulatory)
External contract manufacturing organizations
• BS in Biological Sciences preferred
• 8 or more years of Experience in Regulatory Affairs (preferably on Global programs)