Our client, a Pharmaceutical company in New Jersey is seeking a Regulatory Affairs Manager to join its team.

Salary/Hourly Rate: $85K+ DOE

Position Overview: 

• Design, develop and execute regulatory submissions on a global basis, both NDA and ANDA
• Serve as the company's lead in all regulatory matters with collaboration with internal cross-functional teams and external authorities such as FDA, EMA
• Monitor and manage all strategies, processes, directions and progress of regulatory projects
• Provide up-to-date regulations to company and regulatory staff
• Serve as company's FDA and EMA contact for products and projects 
• Regulatory Affairs Manager will perform documentation of the interaction and decisions from regulatory authorities. 
• Prepare, oversee and coordinate regulatory submissions
• Interact with internal groups to obtain or provide information and updates for regulatory submissions
• Formulate registration strategies and ensure they adhere to corporate objectives

Responsibilities of the Regulatory Affairs Manager: 

• Regulatory Affairs Manager will provide up-to-date regulations to company and regulatory staff
• Serve as company's FDA and EMA contact for products and projects
• Perform documentation of the interaction and decisions from regulatory authorities 
• Prepare, oversee and coordinate regulatory submissions, both NDA and ANDA 
• Interact with internal groups to obtain or provide information and updates for regulatory submissions
• Formulate registration strategies and ensure they adhere to corporate objectives
• Train and mentor junior level regulatory staff

Education Requirements: BS degree in the sciences. Advanced degree highly preferred

Benefits: Competitive benefits package