OTC Labeling Project Coordinator Job in Princeton 08540, New Jersey US
Essential Duties and Responsibilities: Coordinate projects for all new/revised art between India Graphics & Regulatory groups.
Coordinate all labeling projects to be completed in a timely manner to meet customer and/or FDA required implementation dates.
Maintain art, printed component & documentation files (History of Changes).
Insure proper SAP and Change Control implementation.Act as liaison to the FDA in matters pertaining to OTC labeling applications and regulatory compliance.
Provide input and assemble responses to FDA deficiencies.
Review and provide advice on OTC labeling, product claims, marketing brochures and other publications to ensure compliance with regulations.
Review new regulations, policies, guidance documents, USP revisions, etc. issued by relevant regulatory authorities, which may impact the company.
Prepare labeling revisions for marketed OTC products based on updated product information; completion of product labeling updates for marketed products labeling.
Support special projects as assigned such as special department initiatives, new business development with contract distributor/manufacturers.
Responsible for all drug product labeling components associated with our OTC Product lines.
This encompasses our customer requested revisions and FDA mandated changes.
Other activities as assigned by the Manager/Supervisor or Department Head.
Principal Accountabilities (Key Result Areas) List the four to eight main areas in which this job must get results in order to achieve its purpose.
Key Result Areas provide a comprehensive statement of all the key outputs of the job and should: Assuring approval of artAssuring OTC product labeling meets FDA required guide linesMeeting timeframes for scheduled delivery of printed materialsContributing to meeting production dates of finished goodsAssuring the approval of print proofs of all printed componentsSupporting company sales by being able to meet deadlines and making sure both Customer and FDA requirements are met. Requirements - Knowledge and Experience2-5 years OTC regulations and labeling requirements (consumer products / retail) Bachelors Degree Proficiency in regulatory compliance and Rx-to-OTC labeling
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