Regulatory Affairs Consultant (Ciudad de México)

Regulatory Affairs Consultant (Ciudad de México)

07 ago
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Ciudad de México

07 ago

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Ciudad de México

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.
**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
- Integral 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

📌 Regulatory Affairs Consultant (Ciudad de México)
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📍 Ciudad de México

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