Regulatory Affairs Consultant( Labelling
hace 4 semanas
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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.
- 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).
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
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