Sr. Regulatory Affairs Specialist

WORK LOCATION IS DAYTON,NJ

JOB SUMMARY

This will person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products. This position will also interact with other departments and cross functional teams both in US and India.

REPORTING RELATIONSHIPS

Depending on the experience of the candidate, one labeling associate may report to this position.

DUTIES & ESSENTIAL JOB FUNCTIONS

• Regulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests.

• Independently manage preparation (in paper or electronic formats (eCTD and SPL)), submission and monitoring progress of FDA review of ANDA's

• Communication with functional groups for coordination and preparation of data for submission to FDA

• Manage all Regulatory, Federal and State License requirements

• Review change controls for regulatory requirements and according to appropriate regulations and guidance’s.

• Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc)

• Review labels as per FDA guidance

• Regulatory support in drug listing.

• Perform other duties as assigned

WORK LOCATION IS DAYTON,NJ

WORK LOCATION IS DAYTON,NJ

QUALIFICATIONS

• BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy

• 1 - 2 years’ experience in pharmaceutical regulatory affairs (mandatory)

• Attention to detail

• Excellent oral and written communication skills

• Knowledge of US drug regulatory requirements (mandatory)

REQUIRED

BS or MS in Sciences or Pharmacy

PREFERRED

Experience with eCTD filings

Regulatory Affairs Certification (RAC)

WORK LOCATION IS DAYTON, NJ