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Apply for this job: Your application choices are: * Apply for this jobonline * Refer a friend to this job More information about this job: Overview: Teva Parenteral Medicinesis a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity forRA Specialist II/Sr. RA Specialist
Responsibilities:
Provides technical review of all data/reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Travel Requirements Less than 10% domestic and international 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 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 Acts as contact representing Regulatory Affairs for contract and international projects as assigned Reviews and analyzes regulatory and related publications to assure compliance and anticipate future regulatory action. Follow Teva Safety, Health, and Environmental policies and procedures. On time submission and approval of NDAs/ANDAs and supplements. Maintain approved applications in compliance with FDA regulations. Provide appropriate regulatory guidance to research and operations professional staff. Other duties, as assigned, or as business needs require.
Qualifications: Minimum Bachelor’s degree in scientific or healthcare discipline or equivalent combination of education and related experience. RAPS RAC (U.S. or EU) (Preferred) Minimum of 5 years pharmaceutical industry experience with a least 4 years in regulatory affairs RAC certification beneficial, but not required; working knowledge of CMC as needed for ANDA submissions. Prior pharmaceutical experience involving chemistry or manufacturing. Demonstrates an understanding of ICH and FDA guidelines Demonstrates an understanding of R&D processes required for NDA/ANDA submissions Demonstrates proficiency with computer and familiarity with electronic document management. Demonstrates ability to negotiate response to FDA deficiencies in a manner acceptable to both FDA and affected TEVA departments Demonstrates judgment in determining whether an ANDA is sufficiently complete to be accepted for filing by OGD, or whether it will be refused. Demonstrates ability to establish sound professional relationships with other TEVA departments and Government employees. Demonstrates excellent oral and written communication skills, including editing of documents by others. Ability to manage multiple priorities effectively and work independently with minimal supervision. As a 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 Parenteral Medicines 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 . Click Employment Opportunities, then Positions Available and search for Position10-4751. Resumes will be reviewed and qualified candidates will be contacted for pre-screening. Search Firm Representatives Please Read Carefully: Teva is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Teva via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Teva. No fee will be paid in the event the candidate is hired by Teva as a result of the referral or through other means.
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