Senior Associate, Regulatory Affairs, Post Approval Sagent Pharmaceuticals

Primary Function:

Support development of new product filings to FDA and registration maintenance under the direction of RA staff.

Major Duties and Responsibilities:

Support preparation and review of dossiers for FDA submission including ANDAs, 505(b)(2)s, DMFs and 510(k)s in line with regulatory requirements, regulatory guidelines, and GMP compliance.

Coordinate efforts to answer deficiency letters, including establishing regulatory strategies, advising on data requirements, and preparing responses.

Identify, assist with gathering, and evaluate data from partners as needed to support submissions.

Prepare documentation needed to maintain registration of products (Supplements, Annual Reports, DMF updates and Labeling changes).

Administers change control process by reviewing proposed changes against most recent applicable filings to ensure regulations, guidelines, and commitments are satisfied

Review labeling, advertising, promotional materials, study protocols, validation protocols to ensure compliance with applicable regulations and existing regulatory filings.

Managerial Responsibilities:

No direct management responsibilities.

Experience / Technical Competence

2-5 years of Health industry experience. Direct Regulatory Affairs experience preferable.

Educational / Scientific Leadership

A bachelors degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering or equivalent preferable.

Travel

10 domestic and international travel.
Reference : RA
Contract type : Full Time
Job(s) available : 1
Experience required : 4 Years
Studies level required : Bachelors Degree
Working place : Schaumburg, Illinois
Creation date : 06/23/2011.

Location:	1901 North Roselle Road Suite 700 Schaumburg, IL 60195 United States