Regulatory Affairs Specialist
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
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.
Responsible for supporting the management of in-market representative bodies.
Ensures documentation related to regulatory matters, process, and product / label change control
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.
Responsible for assisting/supporting supervisor regarding REACH Law initiatives.
Works with support of supervisor to review, ideate and approve marketing messages, promotional
documents, product claims and labeling ensuring risk-based regulatory compliance for new and
existing products.
Provides regulatory guidance and training as appropriate ensuring compliance with all regulatory
requirements in existing and new markets.
Manages entry of data into WERC’S and generates SDS’s as appropriate.
Reviews global regulations/guidance documents and works with his/her supervisor and
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.
Create Master Batch Records for all new and existing products for production.
Create and maintain product information files (PIFs) for all new and existing raw materials.
Log and maintain all raw materials ordered by R&D and Purchasing
Recognizes urgency and reacts timely with necessary information or actions
Prioritizes actions and activities to meet expectations, including changing expectations.
Adjusts actions in response to situations and available information.
Understands the importance of new information for both current and future problem-solving and
decision-making, with regards to regulation and compliance.
Experience:
Minimum 2 years’ experience in a regulatory role
Hands-on working knowledge of domestic FDA OTC drug product requirements
Experience with FDA inspections
Strong knowledge of cGMPs
Experience with REACH law and WERCs
Experience writing SOPs
Understand MoCRA requirements
Excellent oral and written skills
Open, honest communication skills
Statistical Evaluation of data
Strong computer skills utilizing a Microsoft environment (Word, Excel, Access, Power Point)
Utilizes a database and other digital files to create reports and dossiers.
Reasoning Ability:
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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