Regulatory Affairs Consultant( Labelling

hace 4 semanas

Ciudad de México, Ciudad de México ICON Strategic Solutions A tiempo completo

As a Regulatory Affairs Consultant you will be joining the world's largest & 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 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 on 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 pharmaceutical review and approval process.
  • Experience in leading activities necessary for promotional submissions.
  • Experience with using social media platforms for promotion of prescription drugs in MX.
  • Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat, and Veeva Vault Promo Mats or other electronic review platforms.
You are:
  • Minimum 5 years Pharmaceutical/Biotechnology industry experience, at least 3 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs.
  • Bachelor's degree in a health, life sciences or medical fields.
  • Fluent 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. Our benefits are designed to be competitive within each country and are 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 to maximise savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers website to read more about the benefits of working at ICON: ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.#J-18808-Ljbffr

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