The position of the Regulatory Affairs Specialist I reports to the Manager, and is responsible for the development, retrieval and maintenance of regulatory submissions. This position will work closely with the Manager in the preparation of submissions (notifications & registrations) for new products, product changes, as required to ensure continued compliance, and timely approval for market release of products.
This position will work on cross functional international teams to launch and maintain compliant personal care and nutritional products in the US and international markets. Regular outputs include ingredient and formula reviews, label development, as well as document review. This position will maintain knowledge of current/pending future regulations for ingredients, products, packaging, labeling, claims, and related areas for product lines and markets as assigned
Create and implement strategies with Manager or with multifunctional teams for international regulatory submissions.
Assist in the drafting of product registrations in worldwide markets for line extensions and new product releases. These product registrations may include current markets such as U.S., Canada, Australia, New Zealand, European Union, Asia and Latin American countries.
Support each affiliate/distributor on a case-by-case basis to address product registrations, custom requirements, and negotiations with ministries of health in each respective country.
Helps to coordinate with inter-department team members in the creation, update, maintenance of all Domestic/International technical files and dossiers.
Assist in the development and implementation of procedures for Domestic and International Regulatory Affairs.
Provide on-going support to all levels of Team Members, not limited to Product Development, Quality, and Marketing to facilitate required projects.
Assist Quality/Legal team during inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.
Assist in the creation and maintenance of an International Ingredient Database as a reference for Regulatory and other departments of ingredient’s acceptability within a country.
Responsible for the periodic file maintenance of product registrations, submissions, manufacturer information and GMP status related to Personal Skin Care (cosmetics / drugs).
Assist the Manager in the review of formula ingredients, artwork, artwork maintenance & label claims for compliance.
Prepares / submits periodic reports, special tasks and assignments as required.
Knowledge and Skills:
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