Regulatory Affairs Specialist (Europe)
The Playtex strategic business unit, which is a division of Energizer Personal Care, is a leading manufacturer and distributor of a diverse portfolio of consumer and personal products. Playtex is focused on Feminine Care products, Infant Care products, Sun and Skin Care products. The Technical Consumer Insights group works with R&D to conduct product home-use testing and focus groups with consumers both onsite at the Allendale facility and offsite at other consumer testing facilities.
Primary Purpose of this position:
With some supervision, support product registration, raw material review, and formula review.
Essential Functions:
? Provide day-to-day regulatory support for new product development and commercialization projects.
? Review and approve formulas, raw materials and other product design criteria.
? Prepare regulatory submissions to health authorities to include Notification to Competent Authorities/Registration to Poison Centers for Sun and Shave products and Registration to Biocidal Competent Authorities for Wet Ones.
? Preparing Certificates of Free Sale for Shave Products manufactured in the EU obtaining Certification through EU Competent Authority/Legalization via respective Embassy. Also preparing COFS for US manufactured products when required for Sun/Shave.
? Maintain up-to-date product registrations, including registration expirations, discontinuances or product changes.
? Work with Manager to determine product registration plans and strategies.
? Review and provide Regulatory input to development contracts for minor formula adjustments, line extensions or package changes.
? Review and approve White Papers and Artwork for European products.
? Review product changes to determine impact to existing labeling or registration; provide Regulatory input to change control requests.
? Attending EU weekly/monthly meetings to collaborate with Marketing, Program Management, Operations and other cross-functional team members to meet required deadlines.
? Provide technical Regulatory representation on cross-functional teams, with emphasis on product launch planning and execution.
? Research and monitor changes in standards and regulations that may impact to the business.
? Work with global regulatory staff to help ensure regional regulatory requirements are met.
? Author Standard Operating Procedures for routine Regulatory transactions and work processes.
? Track, identify, measure and communicate trends in Regulatory transactions and initiatives.
? REACH ? specific time allocated per week to support on REACH relative requirements to meet our obligations; to include Substance Volume Tracking, SVHC Tracking and Status Reporting on Supplier Communication.
? PIF Analysis ? to identify any gaps for all EU products to meet European New Cosmetics Regulation in particular Test Data to support New Safety Report.
? Preparation for application of new requirements from European Regulation on: Labeling requirements (Nano); Animal Testing information; CMR monitoring as no lead-time when banned; In-Market Control-Reporting Serious undesirable Effects; Claims- ensuring our Claims meet EU Commission/Industry Common Criteria; Distributor?s New Responsibilities; Public access to information.
? Metrics ? completing metrics covering European completed Notifications and Registration and any other relevant Process in a quarterly report to share with internal customers.
? Overall Status Report to identify obligations? met and enabling communication progress with Manager.
Experience/Education Required:
? Good understanding of European Commission Cosmetics Directive/Regulation, FDA regulations on OTC drugs, cosmetics and medical devices as they apply throughout the product lifecycle.
? Bachelor's Degree, preferably in biology, chemistry, engineering or material science discipline, plus 1-3 years of Regulatory Affairs experience.
? Experience with cosmetic, drug and/or device product registration is required.
? Knowledge of consumer product regulations and/or international regulations is a plus.
? Experience with relational databases, data validation, and report/query set up is a plus.
Skills and Abilities Required:
? Customer service mentality.
? Fast learner with a flexible style and the ability to adjust to changing business priorities.
? Above average computer skills. Proficiency with Word, Excel, Access/databases, e-mail and internet applications; demonstrated aptitude with information technology.
? Highly accountable; solution- and results-oriented.
? Excellent verbal / written communication and interpersonal skills.
? Ability to interface with internal and external contacts at all levels.
? Strong attention to detail. Good record-keeping skills.
? Excellent organizational, prioritization and follow-up skills.
? Ability to handle multiple tasks / projects simultaneously.
? Self-starter with ability to think and act independently and to make sound recommendations.
? Demonstrated ability to complete projects on time.
? Good analytical and problem-solving skills.
? Some light lifting required, up to 25 pounds.
Energizer Personal Care is an Equal Opportunity Employer. M/F/D/V.
Please note that we will only respond to candidates that meet our qualification criteria.
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Consumer Packaged Goods Manufacturing 