Regulatory Affairs Consultant( Labelling

hace 4 semanas


Ciudad de México, Ciudad de México ENGINEERINGUK A tiempo completo

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Regulatory Affairs Consultant (Labelling - Promotionals)

Sector: Research and Development, Science and Pharmaceutical
Role: Consultant
Contract Type: Permanent
Hours: Full Time

As a Regulatory Affairs Consultant, you will be joining the world's largest and most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:

  • Excellent understanding of Cofepris regulations for drug promotion/advertising and labeling, and experience interacting with Cofepris.
  • Experience with Veeva Vault PromoMats or similar document management systems is a plus.
  • Demonstrated expertise in regulatory requirements for labeling and advertising materials.
  • Experience in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance.
  • Knowledge of Common Technical Document and global guidelines on content and format of labeling preferred.
  • Experience with creating and reviewing labeling and advertising materials required.
  • Experience in collaborative multifunctional work teams at the local or global level.
  • Ability to manage multiple tasks and multifunctional resources concurrently, and to respond to rapidly changing priorities and aggressive deadlines.
  • Experience in communicating with all levels of personnel, in local and global environments.
  • Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.
  • Proven ability to provide strategic direction and innovative, forward-thinking regulatory guidance and analyze and interpret efficacy and safety data.
  • Working knowledge of Cofepris regulatory and compliance guidelines on advertising and promotion, including product launches.
  • Good understanding of the advertising/creative development process.
  • Understanding of the pharmaceutical review and approval process.
  • Experience in leading activities necessary for promotional submissions.
  • Experience with using social media platforms for the promotion of prescription drugs in MX.
  • Proficiency in computer applications and configuration, including Microsoft Office and Adobe Acrobat. Proficiency in Veeva Vault PromoMats or other electronic review platforms.
You are:
  • Minimum 5 years of Pharmaceutical/Biotechnology industry experience, with at least 3 years in Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs.
  • Bachelor's degree in health, life sciences, or medical fields.
  • Fluent in English and Spanish (read, write, and speak).
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits focused on well-being and work-life balance opportunities for you and your family.
Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals
  • Life assurance
  • Flexible country-specific optional benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. #J-18808-Ljbffr

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