Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Position Summary :
The Senior Regulatory Affairs Specialist will be responsible for performing a wide variety of tasks to
ensure global compliance with all cosmetic and OTC regulatory requirements. This position will be
responsible for supporting global regulatory programs and strategies by working collaboratively with
his / her supervisor and key business partners. He / she will support new & existing products, process
improvements, and global market compliance as appropriate.
This position will be responsible for supporting and implementation of the required processes, protocols
and programs necessary to support compliant and robust regulatory practices throughout the company.
Functional Responsibilities :
Completes assignments related to FDA and global regulatory compliance matters including
supporting general quality system related initiatives.
are accurate and compliant.
Works collaboratively with cross-functional project teams to complete regulatory related
assignments for both new and existing products. Clearly articulates requirements to colleagues.
Responsible for supporting and taking the lead as appropriate regarding cosmetic / OTC
international product registration’s and the establishment of compliant Dossier’s.
existing products.
colleagues as appropriate to develop strategies that ensure ingredient, packaging component,
printing inks / pigments and finished product compliance.
Monitors, interprets, makes recommendations to update product compositions, company
procedures and documents with respect to forthcoming and / or changing state, US and global
regulatory requirements.
Works with supervisor to develop and communicate regulatory compliance requirements in
support of NPD (New Product Development) Process.
Maintains regulatory files including claims support packages for new and existing products to
ensure compliance and support / defend legal inquiries / challenges and regulatory audits.
Responsible for supporting the timely filing of all US annual licenses for OTC Drugs and
cosmetic personal care products (MoCRA)
Works with supervisor and Department Head to provide regulatory guidance with respect to short
andlong term business planning. Keeps R&D team updated of changing regulations and develops
formulation guidelines.
decision-making, with regards to regulation and compliance.
Experience :
Has the ability to define problems, collect data, establish facts, and draw valid
conclusions in any situation
Has the ability to solve problems and deal with a variety of variables in situations where
only limited information exists
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