Regulatory Affairs Coordinator Positions in Actalent Bridgewater, NJ

Website Actalent

This Jobsfunter Listing is about Actalent in Bridgewater, NJ 2022

About the job

  • IMMEDIATE NEED for Regulatory Affairs Coordinator opening with multinational pharmaceutical company in Central, NJ! Client is actively interviewing and starting candidates within two weeks!*
  • Description Overview of the role:
  • Provide Information and Regulatory Support to International RA team members for Product Registrations, Renewals, Launches, etc. / To provide support and needed information to all global regions on all US products across the client and subsidiaries’ product portfolio so that regions can file products with the needed documentation and information for their submissions.
  • Duties:*
  • Responsible for providing Regulatory Affairs support to International RA teams for product registrations, renewals to global markets for all US approved/cleared products including pharmaceuticals, medical devices, nutritionals and skin care products.
  • The incumbent will provide support for all requested documents (certificates/letters), search and retrieve product labeling & all 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 Apostilled Regulatory Documents
  • 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 requestors (Sharepoint, Clinops, Liquent /Insight viewer) where information can be found.
  • Work with other International Support groups (Operations, QA, etc.) to provide assistance to regions.
  • Additional Skills & Qualifications:*
  • Key relationships:
  • Internal R&D and Business functional groups to support R&D Development projects as well as expand already approved products throughout client regions.
  • Regional functional groups (mainly Regulatory)
  • External contract manufacturing organizations (CMO) and partners
  • BS in Biological Sciences preferred
  • 5 or more years of Experience in Regulatory Affairs (preferably on Global programs)
  • Additional Benefits:*
  • Quick Access to Benefits – Medical, Vision, Dental, 401(k)
  • PTO & Holiday Pay Included
  • Actively Interviewing!

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Company: Actalent

Vacancy Type: Contract · Entry level 

Job Location: Bridgewater, NJ

Application Deadline: N/A

Apply Here