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
Qualifications for the Regulatory Affairs Manager:
Minimum 5 years industry experience preferably from biopharma background
Direct regulatory affairs in registration and submission highly desirable
Thorough knowledge of FDA guidelines essential
Thorough knowledge of CMC essential
Knowledge of global regulatory requirements highly desirable
Effective communication in both verbal and writing capacities essential
Internal Number: 82438
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