Regulatory Affairs Project Specialist I

Teva Sicor Pharmaceuticals is a global leader in the manufacture of generic injectable pharmaceuticals. Now a member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs, TEVA Sicor has an excellent opportunity for Regulatory Affairs Project Specialist I.

Responsibilities:
* Provides technical review of all data/reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Coordinates, prepares, and reviews all appropriate regulatory submissions (e.g., ANDAs, dossiers, amendments, and supplements) for domestic, international, and contract projects.
* Coordinates, prepares, and reviews responses to all deficiency letters within a specified time frame in conjunction with the organization.
* Coordinates and prepares laboratory samples as requested by regulatory agencies.
* Reviews adverse drug reactions and files all related reports per FDA guidelines.
* Provides project management support to Labeling Specialist in development and review of draft
and final printed product labeling.
* Coordinates and reviews development of promotional labeling with Marketing.
* Coordinates and reviews for submission bi-annual Drug Listing with Regulatory Labeling Specialist.
* Prepares and reviews ANDA suitability or citizen's petitions.
* Participates in internal compliance audits as assigned.
* Acts as contact representing Regulatory Affairs for contract and international projects as assigned.
* Participates in organizational committees as assigned.
* Interfaces with FDA regarding the compliance status of GSPI’s applications.
* Liase with FDA regarding general inquiries related to GSPI’s applications.
* Fulfill responsibilities as U.S. Regulatory Agent for Sicor’s DMFs.
* Recommends strategies and supports international registration of products by relaying technical information.
* Coordinates recall/market withdrawal activities when necessary.
* Formulates regulatory strategy to recommend to R.A. management.
* Coordinates regulatory aspects of contract manufacturing projects.
* Reviews and analyzes regulatory and related publications to assure compliance and anticipate future regulatory action.
REQUIREMENTS
Requirements:
* BS/MS in technical discipline or equivalent experience.
* Minimum 4-5 years industry experience with 3-4 years regulatory experience.
* Excellent communication skills (i.e., written and inter-personal).
* Working knowledge of FDA, FD&C, 21 CFR, and FDA guidelines.
* Sound understanding of GMPs, GLPs, and GCPs.
* Knowledge of pre-approval and post-approval inspection program.
* Knowledge of SVP manufacturing, bulk drug manufacturing, and international registration.
* Experience in managing people and/or projects.
* Proficient with computer (Microsoft platform).

As a new member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.

TEVA Sicor offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com. Click Employment Opportunities, then Positions Available and search for Position # 5133. You may also fax your resume to 949-458-8945.