Regulatory Affairs Latam Hub Sr Coordinator

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your responsibilities:
 

Develop and communicate regulatory expectations to both internal and external stakeholders. Create strategies and conduct risk assessments to ensure that submission timelines align with applicable regulations. Prepare and assemble regulatory submission dossiers for local authorities. Collaborate with global, local, and regional teams to ensure submissions are comprehensive and compliant. Maintain systems updated (Veeva, among others). Analyze and review local regulations to identify potential risks and opportunities. Implement strategies to mitigate risks and leverage opportunities based on regulatory changes. Regularly interact with managers regarding activities, issues, and milestones. Build and maintain relationships with third parties and cross-functional stakeholders to enhance performance and resolve critical issues in submission processes. Review and approve labeling, artwork, mockups, and promotional material materials to ensure compliance with regulations. Support the planning, coordination, and preparation of all necessary documents for health authority submissions in the LATAM region. Represent the LATAM region in global forums for specific products or projects. Maintain fluent communication with internal customers to achieve departmental performance goals.

 

Who you are:
 

• Bachelor’s degree in Pharmaceutical chemistry, Biochemical chemist or other Science degree preferred, with minimum of 6 years of experience as a regulatory professional.
• At least 1 year of project management experience is preferred.
• Knowledge and management of regulatory requirements/environment in Mexico and/or Uruguay required. Other LatAm (Bolivia, Paraguay and Venezuela) countries is an asset.
• Perform pre- & post registration activities (including renewals, variations, labelling, promo material) of dossiers and options to obtain product approvals and support product variations.
• Excellent verbal and written communications skills, both in English & in Spanish.
• Ability to interact effectively with all levels of management.
• Effective time management and prioritization skills to manage several initiatives with demonstrated ability to achieve success.
• Proficiency in use of databases, excel, power point.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!