Regulatory Affairs Consultant( Labelling

hace 3 semanas


Ciudad de México, Ciudad de México ICON 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. Proficiency in 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:

At 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.

Interested 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

  • Ciudad de México, Ciudad de México Pharmaceutical Research Associates, Inc A tiempo completo

    OverviewAs a Regulatory Affairs Consultant you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.ResponsibilitiesWhat you will be doing:Excellent understanding of Cofepris regulations for drug promotion/advertising and labeling, and experience interacting with Cofepris. Experience with...


  • Ciudad de México, Ciudad de México Pharmaceutical Research Associates, Inc A tiempo completo

    Regulatory Affairs Consultant Job DescriptionThis position requires a highly skilled Regulatory Affairs Consultant to join our team at Pharmaceutical Research Associates, Inc. The successful candidate will have a strong background in regulatory affairs, with a focus on Cofepris regulations for drug promotion/advertising and labeling.In addition to your...


  • Ciudad de México, Ciudad de México ICON A tiempo completo

    About ICONICON is a leading global clinical research organisation, driven by healthcare intelligence. Our expertise spans drug development, medical device and diagnostics research, as well as therapeutic and diagnostic development. As a regulatory affairs consultant at ICON, you will be part of a dynamic team that supports clients in navigating complex...


  • Ciudad de México, Ciudad de México Pharmaceutical Research Associates, Inc A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Pharmaceutical Research Associates, Inc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with Cofepris regulations for drug promotion/advertising and labeling.The successful candidate will have excellent...


  • Ciudad de México, Ciudad de México Stryker Group A tiempo completo

    Job OverviewThe Stryker Group is seeking a highly skilled and experienced Associate Manager, Regulatory Affairs to join our team. This role will be responsible for coordinating the annual submission plan for new product registrations and renewals, ensuring compliance with COFEPRIS guidelines.About the RoleLead and manage a team of regulatory affairs...

  • Regulatory Affairs Lead

    hace 14 horas


    Ciudad de México, Ciudad de México Goods & Services A tiempo completo

    Regulatory Affairs LeadThe Regulatory Affairs Lead position at Goods & Services plays a vital role in ensuring compliance with regulatory requirements. As a key member of our quality assurance department, you will develop, implement, and maintain regulatory strategies that meet industry standards.Responsibilities:Develop, implement, and maintain regulatory...


  • Ciudad de México, Ciudad de México Tevapharm A tiempo completo

    We are seeking a skilled Regulatory Affairs Manager to join our team at Teva Pharmaceuticals. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with national and international regulations.Your Key ResponsibilitiesMain responsibilities include managing regulatory submissions, reviewing regulatory changes,...


  • Ciudad de México, Ciudad de México Pharmaceutical Research Associates, Inc A tiempo completo

    Join Our Team as a Regulatory Affairs ConsultantWe are seeking a highly motivated and experienced Regulatory Affairs Consultant to join our team at Pharmaceutical Research Associates, Inc. In this role, you will be responsible for ensuring compliance with Cofepris regulations for drug promotion/advertising and labeling.The ideal candidate will have a strong...


  • Ciudad de México, Ciudad de México Merck Gruppe - MSD Sharp & Dohme A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Director to join our team at Merck Gruppe - MSD Sharp & Dohme. As a key member of our regulatory department, you will be responsible for ensuring compliance with local and international regulations, as well as developing and implementing strategies to maintain and enhance our regulatory...


  • Ciudad de México, Ciudad de México Amgen SA A tiempo completo

    Our mission at Amgen SA is to serve patients living with serious illnesses. We believe in the power of collaboration and innovation to drive progress in healthcare. As a Senior Associate Regulatory Affairs Fixed Term, you'll be part of a dynamic team working towards this goal.About the Role:This fixed-term position involves leading regulatory submissions,...


  • Ecatepec de Morelos, México Asphalion A tiempo completo

    Asphalion is growing and we are looking for a Regulatory Affairs Senior Officer with experience within pharmaceutical industrySomeone who loves to take new challenges, to work in an international environment and who wants to grow with usMain responsibilities: • Submissions of NA, variations, renewals and procedures national and worldwide, including EU, US,...


  • Ciudad de México, Ciudad de México Amgen SA A tiempo completo

    Transform the lives of patients by ensuring timely and compliant regulatory submissions for Amgen SA. As a Senior Associate Regulatory Affairs professional, you will play a pivotal role in maintaining the company's reputation for quality and innovation.In this exciting opportunity, you will be responsible for preparing, reviewing, and approving source text...


  • Ciudad de México, Ciudad de México Cavuventures A tiempo completo

    Cavuventures is a pioneering company that empowers individuals to achieve optimal performance and well-being through innovative technologies. We're currently seeking a skilled Regulatory Affairs Specialist to join our Digital Health team.


  • Ciudad de México, Ciudad de México Amgen SA A tiempo completo

    Amgen SA is dedicated to serving patients living with serious illnesses. Our mission drives all that we do, from research and development to manufacturing and delivery of innovative medicines. As a Senior Associate Regulatory Affairs Fixed Term, you will play a critical role in ensuring regulatory submissions meet Amgen's corporate and local...


  • Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

    About the RoleAs a Regulatory Consultant, you will play a critical role in ensuring compliance with global regulatory requirements for Syneos Health's clients. This involves executing commercial Lifecycle Management (LCM) strategies and submissions, reviewing CMC sections of regulatory submissions, and working with regulatory colleagues to develop global...


  • Ciudad de México, Ciudad de México Syneos Health, Inc. A tiempo completo

    Key Performance IndicatorsThe Regulatory Affairs Specialist will be responsible for ensuring the accuracy, completeness, and timeliness of medical writing deliverables, adhering to regulatory standards and company policies. Key performance indicators will include:Timely completion of medical writing projects;Accuracy and quality of written content;Compliance...


  • Ciudad de México, Ciudad de México Tevapharm A tiempo completo

    We are committed to making good health more affordable and accessible for millions of people worldwide. Our team is dedicated to working with the world's leading manufacturer of generic medicines, producing many products on the World Health Organization's Essential Medicines List.The OpportunityAs a Regulatory Affairs Manager, you will play a critical role...


  • Ciudad de México, Ciudad de México Elysian Biologics A tiempo completo

    Direct message the job poster from Elysian BiologicsTalent Acquisition Leader | Diversity & Inclusion | StartupsAbout Elysian Biologics:At Elysian Biologics, we are committed to making life better for patients. Our mission is to improve access to life-changing medicines and enhance the understanding and management of diseases. We are looking for passionate...


  • Ciudad de México, Ciudad de México Elysian Biologics A tiempo completo

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Elysian BiologicsTalent Acquisition Leader | Diversity & Inclusion | StartupsAbout Elysian Biologics:At Elysian Biologics, we are committed to making life better for patients. Our mission is to improve access to life-changing medicines and enhance the...

  • Regulatory Affairs

    hace 3 semanas


    Ciudad de México, Ciudad de México Parexel International A tiempo completo

    A Regulatory Affairs Associate must have a knowledge of the organization's basic consulting models and methodologies as well as basic knowledge of what services the department provides. A Project Leader must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and...