Regulatory Affairs Specialist

hace 1 día

Ciudad de México, Ciudad de México Kenvue A tiempo completo
Job Title: Regulatory Affairs Specialist

Kenvue is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory agency regulations and interpretations.

Key Responsibilities:
  1. 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 to ensure compliance with regulatory requirements throughout the product development lifecycle.
  3. Provide guidance and support to internal stakeholders on regulatory matters, including labeling, advertising, and promotional materials.
  4. Stay up-to-date with changes in regulations and industry standards, and communicate potential impacts to the organization.
  5. Contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements.
  6. Participate in regulatory agency inspections and audits, and assist with the resolution of any findings or observations.
  7. Develop and execute regulatory strategies to ensure compliance with global, regional, and local regulations and guidelines.
  8. 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 and promotional copy material to ensure regulatory compliance.
  10. Maintain and archive regulatory documentation in accordance with regulatory agency regulations and guidelines.
  11. Present status updates on product/project activities to key internal/external stakeholders.
  12. Assist in the development of best practices for Regulatory Affairs processes.
Requirements:
  1. Bachelor's degree in a scientific or healthcare-related field.
  2. 2-4 years of experience in regulatory affairs.
  3. Strong knowledge of COFEPRIS and FDA regulations and guidelines, as well as experience with international regulatory requirements.
  4. Excellent communication and interpersonal skills.
  5. Detail-oriented with strong organizational and project management skills.
  6. Ability to work independently and prioritize tasks in a fast-paced environment.
  7. Experience with medical devices or pharmaceuticals is preferred.
  8. Excellent computer skills in Word, Excel, PowerPoint, Email, and Internet.
  9. Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems.
What We Offer:
  1. 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, Paid Vacation, Volunteer Time, Summer Fridays & More
  3. Learning & Development Opportunities.
  4. Employee Resource Groups.
  5. This list could vary based on location/region.

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.

Kenvue leverages automation tools in its talent acquisition process for efficiency. These tools may help match your skills and experience to a given role and assist in scheduling interviews.

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