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(Remote) Regulatory Specialist II Global

Location: 

Ormond Beach, FL, US

Req ID:  3393
Job Type: 
Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.

Regulatory Specialist II Global


Position Summary:
With modest supervision, this Regulatory Specialist II position can work from home / remote and will provides regulatory support to the successful commercialization of all personal care product categories, with emphasis on Cosmetics, Consumer Goods and OTC drugs in North America (Spanish Speaking would be a plus). Product responsibilities for the Shave Care category include Wet Shave, Shave Preps, Razors and Electric Trimmers.

 

Accountabilities

  • Provide day-to-day regulatory support for new product development and commercialization projects.
  • Confirm product or formula acceptability in local markets.
  • Represent Regulatory in Core Team meetings.
  • Prepare regulatory submissions to health authorities.
  • Maintain up-to-date product registrations, including registration expirations, discontinuances or product changes.
  • Review product changes to determine impact to existing labeling or registration status
  • Prepare responses to inquiries from health authorities as part of the registration approval process.
  • Work with Manager to determine product registration plans and strategies.
  • Provide Regulatory input to change control requests.
  • Review and approve artwork to meet regulatory requirements (US, Canada, EU/UK, Australia, Lat Am, APAC)
  • Collaborate with Marketing, R&D, 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 the business.
  • Work with regulatory colleagues to help ensure regional regulatory requirements are met.
  • Track, identify, measure, and communicate trends in Regulatory transactions and initiatives.
  • Author written procedures for routine Regulatory transactions and work processes.
  • Maintain matrices and tracking sheets for Regulatory transactions.
  • Perform administrative functions in support of Global projects.

 

Required Skills and Experience

  • Bachelor's degree, preferably in biology, chemistry, engineering, or material science disciplines
  • 5 years relates experience
  • Regulatory Affairs experience preferred.
  • Sound knowledge of Global Regulations for Cosmetic, OTC and Consumer Products required.
  • Good computer skills. Proficiency with Word, Excel, Access/databases e-mail and internet applications.
  • Excellent verbal / written communication and interpersonal skills.
  • Ability to interface with internal and external contacts at all levels.
  • Strong attention to detail.

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Edgewell is an equal opportunity employer. We do all we can to create a collaborative and diverse global team, where good ideas can thrive, and our colleagues can learn and lead. We prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any legally protected status in accordance with applicable federal, state and local laws. We listen deeply and speak directly to create an environment that’s open to difference. We aim to bring joy to not only the products we create and the people we serve, but our colleagues across the globe too.