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*Blank Template - Professional
Ref No.: 17-06618
Location: Vernon Hills, Illinois
Start Date / End Date: 10/30/2017 to 10/28/2018
Manager, Regulatory Affairs

*This position is responsible for managing various regulatory licensing activities for the Infection Prevention business unit of Client.
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.

This position is responsible for:
• 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 (Client), Changes Being Effected (CBE), IND Amendments and Annual Reports (AR).

*Qualifications:
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

*What are 3-5 “Must Have’s”
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.

*What are 3-5 “Nice to Have’s”?
Knowledge of healthcare-related regulatory bodies such as FDA, MHRA, ISO, Health Canada etc.
Experience in Quality Assurance.