Regulatory Affairs Sr Associate
- Job ID:
- Date:12/15/2008
- Location:Detroit
- State:Michigan
- Salary:Not Specified Why?
- Job Types:
-
Pharmaceutical Regulatory Affairs
Job Description
Regulatory Affairs Sr Associate
Detroit, MI
Duration: Full Time
Job Description
Will prepare, review and submit labeling for various applications, i.e., Original ANDA’s, amendments, ANDA Supplements and ANDA Annual Reports. Responsible to perform necessary drug listing and establishment registration activities. Assist RA Associate Director or designee in all regulatory submissions to the FDA and any follow-up correspondence. Compile, review and evaluate acceptability for filing of labeling to FDA.
Essential Functions:
• Prepare, review and compile labeling for original ANDAs, ANDA supplements, ANDA annual reports in accordance with company SOPs, and according to current FDA guidance and regulations.
• Prepare response to labeling deficiencies received from FDA and, prepare post approval supplements for approved products
• Perform necessary drug listing and establishment registration activities
• Prepare finished product labeling and draft advertising copy to assure compliance with FDA regulations.
• Monitor and inform the group regarding the labeling changes mandated by FDA and any updates to the RLD labeling
• Revise the labeling according to the current RLD labeling and per FDA recommendations and file necessary submissions to FDA
• Responsible to keep track of labeling changes, labeling submissions to FDA an implementation schedule
• Monitor the electronic orange book for any patent and exclusivity updates for the products manufactured and distributed by Caraco and update the group accordingly
• Coordinate with other departments, like, Document Control, Material Management, Quality Assurance, Technical Services and Manufacturing to obtain information required to prepare labeling.
• Review packaging supply master documents and associated documents for current labeling and container/closure systems.
• Coordinate with outside vendors for labeling design and preparation of the art work
• Should be well conversant with electronic labeling rule and different aspects of electronic labeling submissions
• Other duties, as assigned or as business needs require
Required Skills
Education:
BA/BS in science or related field, position to be commensurate with education and pharmaceutical industry experience. 2-3 years experience in labeling design and review is required.
Knowledge, Skills & Abilities:
•Self-motivated and flexible individual who is able to manage multiple tasks and priorities within a fast-paced environment
•Strong working knowledge and application of FDA regulations and requirements
•Strong interpersonal and organizational skills
•Strong verbal and written communication and organizational skills
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