Regulatory Affairs Associate

  •  

Morristown, NJ

Industry: Business Services

  •  

Less than 5 years

Posted 36 days ago

  by    Amanda Jacob-McKim

Recruiting Excellence Since 1989 Davalyn Corporation is a pre-eminent executive search firm. Our philosophy is operational excellence, total commitment to clients and the best professional standards in national and international markets.

Our very high completion rate and the strong level of repeat business from our major clients are our best references. Working in partnership with our clients, we track down and attract the leaders in the corporate world. We seek only those who are effective in what they do and are marked out as achievers in their field. In an increasingly competitive marketplace for top-caliber talent, Davalyn Corporation offers results-driven professional recruiting services to help our clients thrive.

Search underway for a Regulatory Affairs Associate to join our client, a pharmaceutical company.

Responsibilities:

  • Providing support for post marketing related update for IND/NDA
  • Providing support for CMC submissions and input for CMC related changes
  • Providing support for review of technical documentation including specification, product development, process validation, analytical test method and stability data prior to FDA submission
  • Coordinating review of labeling and promotional materials, and maintaining files
  • Assisting in the preparation of regulatory submissions and maintaining central files
  • Assisting in the preparation and review of technical transfer packages and ensuring compliance with the registered application
  • Interfacing with internal and external partners to ensure Regulatory Compliance requirements are met
  • Assisting in preparation of presentations to the management team
  • Preparing labeling and regulatory change controls and managing review and approval process


Qualifications:

  • Bachelor Degree
  • 3-5 years of experience within pharmaceutical regulatory affairs
  • Sterile and injectable product experience is required
  • Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Project)
  • Proficiency in use of databases

Salary

$80K - $100K