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Regulatory Affairs Specialist

hace 2 meses

Ciudad de México, Ciudad de México Kenvue A tiempo completo
About Kenvue

Kenvue, part of the Johnson & Johnson Family of Companies, is a leading healthcare company that believes in the extraordinary power of everyday care. With a rich heritage and propelled forward by science, our iconic brands are trusted by millions of consumers who use our products to improve their daily lives.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions, and organizing and maintaining reporting schedules for new drug application and investigational new drug applications.

Key Responsibilities:
  1. Develop and Maintain Regulatory Strategies: Develop and maintain regulatory strategies and submissions for new products and changes to existing products in alignment with industry standards and regulations.
  2. Collaborate with Cross-Functional Teams: Collaborate with cross-functional teams to ensure compliance with regulatory requirements throughout the product development lifecycle.
  3. Provide Regulatory Guidance: Provide guidance and support to internal stakeholders on regulatory matters, including labeling, advertising, and promotional materials.
  4. Stay Up-to-Date with Regulatory Changes: Stay up-to-date with changes in regulations and industry standards, and communicate potential impacts to the organization.
  5. Contribute to Quality Systems: Contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements.
  6. Participate in Regulatory Agency Inspections: Participate in regulatory agency inspections and audits, and assist with the resolution of any findings or observations.
  7. Develop Regulatory Strategies: Develop and execute regulatory strategies to ensure compliance with global, regional, and local regulations and guidelines.
  8. Prepare Regulatory Submissions: Prepare and compile high-quality regulatory submissions, responses to regulatory agencies questions, and other correspondence in accordance with regulatory agency regulations and guidelines.
  9. Review and Approve Artwork: Review and approve artwork and promotional copy material to ensure regulatory compliance.
  10. Maintain Regulatory Documentation: Maintain and archive regulatory documentation in accordance with regulatory agency regulations and guidelines.
  11. Present Status Updates: Present status updates on product/project activities to key internal/external stakeholders.
  12. Develop Best Practices: Assist in the development of best practices for Regulatory Affairs processes.
Qualifications

We are looking for a highly skilled and experienced Regulatory Affairs Specialist with a strong background in regulatory affairs and a proven track record of ensuring compliance with regulatory agency regulations and interpretations.

  1. Bachelor's Degree in a Scientific or Healthcare-Related Field: Bachelor's degree in a scientific or healthcare-related field.
  2. 2-4 Years of Experience in Regulatory Affairs: 2-4 years of experience in regulatory affairs.
  3. Strong Knowledge of COFEPRIS and FDA Regulations: Strong knowledge of COFEPRIS and FDA regulations and guidelines, as well as experience with international regulatory requirements.
  4. Excellent Communication and Interpersonal Skills: Excellent communication and interpersonal skills.
  5. Detail-Oriented with Strong Organizational and Project Management Skills: Detail-oriented with strong organizational and project management skills.
  6. Ability to Work Independently and Prioritize Tasks: Ability to work independently and prioritize tasks in a fast-paced environment.
  7. Experience with Medical Devices or Pharmaceuticals: Experience with medical devices or pharmaceuticals is preferred.
  8. Excellent Computer Skills: Excellent computer skills in Word, Excel, PowerPoint, Email, and Internet.
  9. Attention to Detail with Excellent Documentation Skills: Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems.
What We Offer
  1. Annual Base Salary: Annual base salary for new hires in this position ranges from $XXX to $YYY. This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
  2. Paid Company Holidays and Vacation: Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
  3. Learning and Development Opportunities: Learning & Development Opportunities.
  4. Employee Resource Groups: 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.