Noven Pharmaceuticals, Inc - Jersey City, NJ
Regulatory Affairs Specialist (Biotech)
This is an entry-level position whereby the primary responsibility for the position is to learn and provide support on the necessary aspects involved with the preparation of all regulatory submissions including INDs/NDAs/ANDAs, amendments, annuals reports and safety reports. This individual will support priority projects with supervision of senior Regulatory Project Leads to file IND/NDA and participate in other regulatory related activities (i.e. FDA milestone meetings, Advisory Committees, FDA workshops, etc.).
There will be the opportunity to primarily participate and eventually lead activities for the Regulatory Intelligence program. The regulatory intelligence program consists of researching, analyzing, interpreting, communicating and acting on intelligence relative to the regulatory landscape, submission routes and existing and/or emerging competitor products to drive compliance and competitive advantage.
Competencies: Demonstrate excellent leadership, communications, and interpersonal skills. Knowledge of regulatory requirements, guidance's and regulations (US and international) within the pharmaceutical industry is desirable. Experience with general submissions along with Regulatory Intelligence activities is highly desirable.
Education / Experience:
A minimum BS/BA Degree required preferably in life sciences.
Entry Level Position – Responsible to learn and assist with Key Responsibilities
Previous experience in the Pharmaceutical Industry desired (+1 years, can include internship and externship experience)
Work Environment: Office setting, ergonomic cubicle workspace, laptop and desktop provided
Physical Demands: Ability to utilize computer in seated or standing position