Regulatory Affairs Consultant
hace 3 días
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 CofeprisExperience with Veeva Vault PromoMats or similar document management systems a plusDemonstrated 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- 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
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