Regulatory Affairs Specialist

Fully remote (EST and CST)

Position Summary : Under general supervision, the Regulatory Affairs Specialist II will support global product registration / notification / listing submissions, NPD / Commercial and global expansion initiatives for all Edgewell product categories, in an office setting, in support of the successful commercialization of Edgewell products, with emphasis on cosmetics and OTC drugs.

Accountabilities

• Co-leads the provision of documentation required to respond to inquiries from competent health authorities
• Manages product registration, notification, listings, portfolios, for assigned regions and product value streams.
• Maintains PIFs / technical dossiers tracking sheets or logs.
• Maintains internal registration / listing / notification regulatory guidance documents, requirements matrices, roadmaps, and databases.
• Supports any company effort to automate PIF / technical dossier building.
• Reviews, organizes, and assists with management of GRAPS SOP's and work instructions.
• Directly supports the completion of surveys or technical sheets received from retailers, globally, as well the compilation and assembly of documentation needed to complete such surveys or to respond to specific inquiries.
• Supports coordination of registration / notifications / listings submissions with regional regulatory lead.
• Assembles product information files (PIFs) / technical dossiers in support of product registrations / notifications / listings in all regions of the world where Edgewell conducts business, to ensure compliance with all pre and post market expectations of competent authorities.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning.

We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.

Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.