Job Description
Regulatory Affairs Asst Manager
Wixom, MI
Duration: Full Time
Job Description
Provides assistance to the Director/Sr. Manager of Regulatory Affairs in maintaining the daily operations of the Regulatory Affairs Department. Assist in all regulatory submissions to the FDA and any follow-up correspondence. Compile, review and evaluate acceptability for filing of ANDA’s, ANDA Supplements and ANDA Annual Reports, as well as assembly of abbreviated new drug applications. Assist Director/Manger in the processing of annual facility and product registrations for the Food and Drug Administration, DEA, State/Local licensing agencies, vendors and other pharmaceutical manufacturing companies
Essential Functions:
• Review and compile all ANDA documents in accordance with company SOPs, GMP’s, GLP’s and other FDA guidelines.
• Review manufacturing/Quality Control change control documents.
• Assist the Director/Manager of RA to maintain compliance with Federal and State Regulatory Licenses including FDA, DEA and Import/Export.
• Prepare finished product labeling and draft advertising copy to assure compliance with FDA regulations.
• Coordinate with other departments, like, Document Control, Quality Control, Quality Assurance, Technical Services, and Manufacturing to obtain all the CMC documents required for ANDA, Supplements, Annual Reports, Periodic Reports and Amendments.
• Maintain and track regulatory files, records.
• Able to review and supervise Regulatory Affairs Associates and Sr. Associates work and provide guidance to them as and when required.
• Responsible for tracking ANDA and other filings to FDA
• Responsible to evaluate departmental needs and provide input to Manager/Director for preparing budget
• Represent regulatory affairs on project teams
• Perform searches/analyses to address specific regulatory questions or issues
• Ensure timely and effective completion of Product Approval Submissions (e.g.ANDA, PAS, CBE-30, CBE etc) per company objectives by working with other departments like QA/QC/R&D
• Implement RA training
• Review regulatory documents such as Change Requests, Incident Reports and Validation Protocols and Reports for concurrence with Product-specific Regulatory Requirements.
• Review manufacturing change control, PSMD’s, Stability Reports and critical Validation Reports.
• Responsible for initiation of new SOPs and updating current departmental SOPs as and when required.
Required Skills
Knowledge, Skills & Abilities:
• Formal training in a regulatory affairs professional (or RAPS) program a plus.
• Good written, oral communication and organizational skills.
• Knowledge of electronic labeling and eCTD format for Bio submissions preferred.
• Computer knowledge required.
• Attention to detail required for review of ANDA submissions.
• Able to work as a team and meet critical deadlines.
• Competence in applying scientific principles and logical thought processes in preparing regulatory documentation
Education:
BA/BS in science, pharmacy or related field. Regulatory Affairs Certification (RAC) or equivalent is essential. Position to be commensurate with education and pharmaceutical industry experience. 3-5 years experience in regulatory affairs is required.
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