Regulatory Affairs Principal Specialist
Posted on Apr 5, 2021 by GOJO Industries
Provides regulatory support to meet department and corporate objectives for both on-going business and new product development. Work has primary emphasis on FDA regulated topical cosmetic and antiseptic drug products on national and international levels.
Essential Functions and Responsibilities
Provides on-going, daily regulatory and technical support to R&D, Marketing, Sales, customers and others as needed.
Evaluates potential product offerings and provides guidance on appropriate regulatory pathways.
Collaborates with product development teams to assess product claims for compliance
Works with industry trade groups to advance regulatory positions advantageous to the enterprise.
Creates regulatory timelines and integrated development timelines.
Conducts complex and vital work, unsupervised and with complete latitude for independent judgement.
Prepares and submits FDA regulatory submissions, ensuring timeliness, accuracy and completeness of submission materials.
Monitors the progress of FDA regulatory filings.
Researches regulatory changes that may affect products and proactively provides updates to the organization on changes.
Remains knowledgeable of the regulatory and legal frameworks, regulatory requirements, and legislation applicable to the organization to ensure that products adhere to all relevant regulatory requirements.
Serves as liaison with regulatory agencies.
Knowledgeable of emerging trends and influences best practices within discipline.
Provides recommendations in response to emerging regulatory issues.
Conducts the copy review of labels, labeling and graphics, in accordance with regulatory requirements.
Provides guidance to development teams on appropriate content and format of submission deliverables.
Conducts periodic regulatory strategy sessions.
Handles regional registrations.
Continuously improves work processes, productivity and accuracy of regulatory function.
Education and Experience
BS, MS and/or PhD degree in technical field or applied sciences or equivalent experience and capabilities. A higher degree is desirable.
Eight (8) to ten (10) years direct or related FDA topical product regulatory background.
Mentors and/or supervises less-experienced team-members and displays leadership as needed. Some multidisciplinary project team leadership.