Essential Duties and Responsibilities include the following and
other duties as assigned:
Understand the regulatory landscape of the company's North
American markets and create strategies which will ensure that the
planning and execution of each regulatory filing is managed
effectively and efficiently, on schedule and within budget.
Work directly with regulatory contacts in all markets, including
company personnel, legal counsel, regulatory consultants and
government agencies in order to register/notice the companys
products and comply with applicable regulations and laws.
Work closely with Research and Development, Quality Assurance
and Purchasing organizations to obtain the documents required to
register/notice the company's products, to include product testing,
product safety, manufacturing processes, labelling and product
Ensure that marketing materials are compliant in relevant
markets and maintain/manage documentation files.
Coordinate with Project Managers regarding regulatory timelines
Have a working knowledge of relevant product laws and
Education / Experience
Bachelors degree, a graduate degree is preferred.
5+ years applicable experience and/or training.
Comprehensive knowledge of laws and regulations applicable in an
FDA- and FTC-regulated environment.
Familiarity with the food, dietary supplement, and cosmetic
Project management capability.
Strong oral and written communication skills.
Ability to respond to inquiries from regulatory agencies,
customers and business community.
Ability to organize large amounts of information with attention
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.