Regulatory Affairs Associate

REGULATORY AFFAIRS ASSOCIATE
Barr Pharmaceuticals, Inc. a holding company, is a global specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. Operating through its principal subsidiaries including Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and Pliva d.d. and its subsidiaries, the Barr Group of companies markets more than 120 generic and 25 proprietary products within the U.S. and more than 550 products internationally.

With more than 8,000 employees worldwide who share a commitment to bringing these affordable generic and unique proprietary products to our customers, Barr has annual revenues in excess of $2 billion through our commitment to and significant investment in new product research and development.

We have an outstanding career opportunity for a successful Regulatory Affairs Associate located in our Bala Cynwyd, PA offices.

Position Summary:

This position offers the ability to work with our dynamic Regulatory Affairs team in supporting the development, submissions and approval for our leading edge proprietary product line. This is an excellent opportunity for a success driven professional with a strong regulatory affairs background to join a fast paced, rapidly growing organization.

Responsibilities include: Organize and compile submissions to regulatory agencies for our proprietary product line Review documents for IND and NDA regulatory submissions, including but not limited to: IND activity. Original IND, clinical trial protocols, clinical study reports, amendments, IND Safety Reports, IND Annual Reports; NDA activity: Original NDA?s (sNDA), NDA Annual Reports Respond to FDA information requests in a timely manner Review and approve initial drug shipment packages for all company sponsored on-going clinical trials. Process promotional material submission via FDA 2253 to DDMACPosition Requirements include: BS Degree - scientific discipline preferred 1+ years regulatory affairs experience within the pharmaceutical industry Working knowledge of IND and NDA processes Familiarity with FDA and Regulatory guidelines (21 CFR and GCP) Superior communication skills - both oral and written Proven ability to work in a team environment Strong computer skills - MS OfficeCommitment to Excellence - Many companies talk about it. Barr delivers - every day, to our customers AND to our employees. Barr's commitment to employees is reflected in our total compensation and benefits package that includes competitive salaries and incentive compensation programs, career opportunities offering both personal and professional growth; a 401(k) plan that matches up to an additional 10% of your pay each year; a stock purchase plan that allows you to buy company stock at 15% below market; comprehensive medical and dental plans that provide coverage for you and your family with nominal employee cost; life and disability protection programs and so much more! Together, we raise the BARR!

We are an Equal Opportunity Employer m/f/d/v.