Regulatory Affairs Manager

New
  • Location
    Vernon Hills, Illinois
  • Job type
    Direct Hire
  • Category
    Medical & Science - Regulatory

A Regulatory Affairs Manager role in Vernon Hills, Illinois is available through Adecco Medical and Science. The primary focus of this position is to be responsible for managing various regulatory licensing activities for the Infection Prevention business unit. The position offers a unique opportunity to join a growing drug Regulatory team that manages both New Product Development and Life Cycle Management activities of currently marketed drug products. Additionally, the team also supports several on-going and future clinical studies under INDs and manages some device products which provides growth opportunity for a diverse Regulatory experience. You must have drug regulatory experience with hands-on experience with writing domestic US FDA submissions. This a direct-hire opportunity starting immediately.

The Regulatory Affairs Manager job responsibilities include:

Responsibilities:

Orchestrating the format and information in the development of regulatory submissions including New Drug Application (NDA), ANDA's and INDs in accordance with the current FDA requirements.
Writing domestic drug regulatory submissions/licenses including New Drug Application (NDA), ANDA's, INDs, NDA Supplements: Prior Approval Supplements (PAS), Changes Being Effected (CBE), IND Amendments and Annual Reports (AR).

Minimum Requirements:

Must have US FDA / CDER drug submission experience.
Minimum BA or BS required, preferably in a scientific or health related discipline.
Minimum of 3 years of experience in Regulatory Affairs with Pharma and/or Medical Device firms.
Demonstrated ability in preparation of accurate documents for drug submissions to US FDA.
Superior attention to detail and organizational abilities.
Comprehensive research abilities.
Effective oral and written presentation / communication skills with cross-functional teams.
Comprehensive coordination and compilation of documentation.
Ability to execute defined projects with minimum management guidance.
Project coordination and management abilities.

If you are interested in this Regulatory Affairs Manager role in Vernon Hills, Illinois then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled



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Reference number US_EN_2_102814_321954