Regulatory Associate--IMMEDIATE OPENING!!!

About the Company:

Jubilant Pharmaceuticals, Inc. (www.jubilantrx.com) is part of a large multinational rapidly growing, fully integrated pharmaceutical company, currently undergoing a large expansion in our U.S. generic ANDA business.  Our company combines the success of Research and Development and manufacturing in both the U.S. and India to develop and market an impressive pipline of generic products.  We have a presence across the pharmaceuticals value chain right from drug discovery services, custom research and manufacturing services, advance intermediates and fine chemicals to active pharmaceuticals ingredients, doseage forms and regulatory affairs services. Through a variety of initiatives, we are striving very hard to make Jubilant Pharmaceuticals a great company to work for and a premier company in our market.

 

Due to recent expansion and growth, Jubilant Pharmaceuticals, an international generic drug manufacturer, has an IMMEDIATE OPENING for a Regulatory Associate position in our Salisbury, Maryland facility.  Relocation Assistance is available for this position.  Successful candidates must be able to relocate to Salisbury, Maryland upon acceptance of the offer.

 

REQUIREMENTS:

**BS Degree (scientific discipline such as Chemistry, Biology, Pharmacy preferred)

**3-5 years experience in the Pharmaceutical Industry (2+ years Regulatory Affairs preferred)

**Familiar with FDA Regulatory Requirements

**Experience in labeling, preparation and submission of ANDA?s

**Proficient with MS Office

**Excellent writing skills

**Strong proofreading skills and attention to detail

**Ability to work effectively with minimal supervision

 

RESPONSIBILITIES:

**Assist in the review, compilation and submission of paper and/or electronic ANDAs

**Assist in preparation of responses to CMC and other deficiency letters and other communications with the FDA to obtain ANDA approvals

**Assist in the preparation and submission of supplements and Annual Reports

**Assist in preparation of Regulatory Departments SOPs

**Preparation of labels and labeling outserts for ANDA and Production which will include word processing, typing, proofreading, etc.

**Work with the printing company to complete production of labels

**Assist with handling of product and medical inquiries

**Respond to product complaints, and assist in the maintenance of product complaint files

 

BENEFITS:

*Your choice of two highly competitive medical plans offered through Blue Cross/Blue Shield
*Your choice of two dental plans
*Company-Paid Life Insurance
*Company-Paid Long Term Disability
*401K Retirement Plan with 100% Vesting and Company Matching Upon Completion of Two Years Service!
*Optional Supplemental Life Insurance
*Annual Bonus Program
*Small company benefits---great opportunity to get wide breadth of experience in your position
*Progressive working environment!

 

FOR IMMEDIATE CONSIDERATION:

*Email your resume to cheston_reisler@jubl.com  (preferred)
*fax it to 410-860-8719