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Principal Scientist - OTC Quality & Compliance

Functions: Manage FDA OTC drug regulatory activities, collaborate with Operations on issues related to regulatory quality, and provide guidance on compliance risks Support R&I laboratories and brands on cosmetic and OTC product development and compliance needs  Responsibilities: Monitoring and addressing new FDA regulatory activities and assessing their potential impact Developing policy/position statements to help guide R&I product development, as well as Regulatory-related quality activities from conception thru commercialization to ensure compliance with OTC drug regulations. Support active NDA. Liaise with contract manufacturers to support Regulatory-related quality issues. Support/address OTC drug compliance issues Experience as FDA liaison for OTC monograph activities and NDA requirements Liaise with Raw Material group to provide direction for identifying new API codes used in OTC drug new development. Provide support to R&I laboratories and brands on cosmetic and OTC product development and compliance needs   Qualifications: B.S. degree or higher in a technical discipline, preferably in biology, chemistry, other life sciences or bioengineering. Minimum 10 years' experience in OTC drug regulations with relevant experience in OTC quality regulatory requirements Experience in cosmetic product compliance and international product registrations. Proficient in using Microsoft Word, Excel and PowerPoint. Knowledge in BI/BO is a plus. Strong communication and project management skills Must be able to handle multiple tasks and attention to detail
Salary Range: NA
Minimum Qualification
11 - 15 years

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