Regulatory Affairs Specialist

hace 2 días

Xico, México Kenvue A tiempo completo
{"title": "Regulatory Affairs Specialist", "content": "Job Summary

Kenvue is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City. As a key member of our Regulatory Affairs department, you will be responsible for developing and maintaining regulatory strategies and submissions for new products and changes to existing products.

Key Responsibilities:

  • Develop and maintain regulatory strategies and submissions for new products and changes to existing products in alignment with industry standards and regulations.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements throughout the product development lifecycle.
  • Provide guidance and support to internal stakeholders on regulatory matters, including labeling, advertising, and promotional materials.
  • Stay up-to-date with changes in regulations and industry standards, and communicate potential impacts to the organization.
  • Contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements.
  • Participate in regulatory agency inspections and audits, and assist with the resolution of any findings or observations.
  • Develop and execute regulatory strategies to ensure compliance with global, regional, and local regulations and guidelines.
  • Collaborate with cross-functional teams to plan, conduct, and manage regulatory activities to meet department and company objectives.
  • Prepare and compile high-quality regulatory submissions, responses to regulatory agencies' questions, and other correspondence in accordance with regulatory agency regulations and guidelines.
  • Review and approve artwork and promotional copy material to ensure regulatory compliance.
  • Provide solutions to complex problems and ensure quality and compliance in all actions.
  • Maintain and archive regulatory documentation in accordance with regulatory agency regulations and guidelines.
  • Present status updates on product/project activities to key internal/external stakeholders.
  • Assist in the development of best practices for Regulatory Affairs processes.

Requirements:

  • Bachelor's degree in a scientific or healthcare-related field.
  • 2-4 years of experience in regulatory affairs.
  • Strong knowledge of COFEPRIS and FDA regulations and guidelines, as well as experience with international regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Detail-oriented with strong organizational and project management skills.
  • Ability to work independently and prioritize tasks in a fast-paced environment.
  • Experience with medical devices or pharmaceuticals is preferred.
  • Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems.

What We Offer:

  • Competitive Benefit Package.
  • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More.
  • Learning & Development Opportunities.
  • Employee Resource Groups.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.", "lang_code": "en-US"}

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