Regulatory Affairs Manager

Regulatory Affairs Manager
Pharmaceutical Industry
Location: Near Oakland, NJ

COMPENSATION
Full Benefits, Bonus Eligible

DESCRIPTION
Prepares, reviews and submit regulatory submission which includes Annual Reports, ANDA’s and supplement to ANDAs or NDAs to the FDA based on guidelines and federal laws. Familiar with pharmaceutical development cycle.

RESPONSIBILITIES
• Suggest amendments in ANDA’s and NDA’s for submission to USFDA.
• Planning and coordination with different departments for timey submission.
• Response to USFDA with some guidance.
• Developing and maintaining staff competence for developed and marketed products.
• Direction to technical team in new ANDAs and NDAs.
• Implement strategy for goal submission.
• Additional documents to support post approval changes for accepted ANDAs and NDAs.

QUALIFICATIONS
• 5 to 7 Years of Supervisory experience.
• Master’s Degree in science related discipline.
• Knowledge of regulations related to ANDA Submission, current CMC and labeling.
• Strong product knowledge for interaction with R & D team.
• At least 5 years of Generic Drug, ANDA, CMC and labeling experience.