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As a Senior Manager within the Regulatory Affairs Labeling group, principal duties are as follows with one or more of these responsibilities divided among other team members as necessary for efficient workflow: Lead Product Label Review Team (PLRT) meetings for assigned marketed product, ensuring the timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes and follow-up of action items to complete resolution.
Provide strategic Labeling guidance to authors regarding appropriate content, FDA regulations, and FDA guidances.
Interact with business partners and provide strategic guidance as appropriate to ensure consistency and compliance of product labeling and proactive communication of potential deviations.
Significant involvement with Manufacturing and Marketing for ensuring timely implementation of revised labeling in production and marketing activities.
Manage outside vendor conversion of package inserts from MS Word or PDF to SPL format. Convert existing package inserts into Physician Labeling Rule (PLR) format, as needed.
Prepare and maintain official Allergan labeling files (hard copy and electronic), including labeling history documents.
Review and analyze labeling files for historical information; prepare and review labeling section of NDA Annual Reports.
Coordinate preparation of regulatory labeling submissions initiated by Regulatory Affairs with contributing functions in other departments.
Review for completeness, consistency and accuracy of proposed changes and supportive documentation, making recommendations or suggestions back to the Project Teams or Regulatory Strategistsas appropriate.
Support Regulatory Strategists as appropriate to achieve timely labeling reviews/approvals. Assist with development of labeling for late stage NCEs/NBEs.
Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidances.
Review regulatory developments and keep Allergan abreast of changes in the US regulatory environment impacting product labeling.
Assist with training of Regulatory Affairs and other functions re: labeling processes as appropriate.
Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.
Minimum B.S./B.A. degree with 5-8 years pharmaceutical experience in DRA or scientific discipline, with 2 years labeling experience.
Experience drafting and reviewing product labeling and compiling supportive documentation, and demonstrated competence in marketed product labeling maintenance.
Capable of reviewing regulatory implications of non-clinical and clinical data to evaluate the regulatory implications for product labeling with substantial support and supervision.
Basic knowledge of US regulatory labeling requirements. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liason) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
Detail-oriented, well organized and good planning skills.
Excellent proofreading/editing skills are required.
Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
Education Bachelors Degree required
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