Job Description

Regulatory Affairs Associate

Summary

This position is full-time located in the Fairfield, NJ office. Some travel will be required. The job involves all aspects of Regulatory Affairs for Pharmaceutical API’s and Finished Dosage. This position is focused on the USA with our ANDA and NDA filings but will also have responsibility for Europe and Japan. This position reports to the President and work closely with corporate leadership.

Responsibilities

• Manage and monitor preparation, submission and review of regulatory documentation in collaboration with all regulatory filings (DMF/ANDA/NDAs/PDMA/CEP). 
• Act as an in-house regulatory expert, advising and supporting, all countries associated with Garonit Pharmaceuticals (NA, Europe, and Japan)
• Lead the implementation of global regulatory strategies taking into consideration the overall development program objectives.
• Provide regulatory support to our global customers. Proactive leadership that supports our customers.
• Monitor process for new product development
• Plan and review all Finished Dosage Filings
• Involved in procurement of ANDA/NDA’s

Qualifications

• Must have experience in preparing and filling ANDA, NDA application with US FDA
• Strong working experience with a variety of regulatory authorities is required, with real firsthand experience of managing registrations with different regulatory authorities
• Experience in leading and managing complex/virtual networks suppliers and partners to deliver and maintain regulatory approvals is essential
• Proven track record in influencing and shaping optimal regulatory outcomes
• Experience with FDA and other regulatory authorities
• Proven ability to work effectively in a team environment
• Professional experience as part of a regulatory agency would be useful

Education & Experience

• Bachelor’s degree in science (Master’s in discipline would be preferred).
• Minimum 3-5 years’ regulatory experience in the pharmaceutical industry

Benefits

· Health Insurance

· Dental Insurance

· Vision Insurance

· 401K

· Paid time off

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