Regulatory Affairs 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

Be in charge of Regulatory Affairs activities, related to healthcare product registration and maintenance, which benefit our patients. Be a strategic partner and interact with internal and external stakeholders, including the Health Authorities. Analyze and review local regulations to identify potential risks and opportunities. Implement strategies to mitigate risks and leverage opportunities based on regulatory changes. Regulatory and Competitive Intelligence (follow up on all relevant matters and publications related to the company, competitors, the Health Authority and trade associations to disseminate internally), as needed.

Create strategies and conduct risk assessments to ensure that submission timelines align with applicable regulations. Careful review of the dossier to be submitted to ensure compliance with regulations. Review and approve labeling, artwork, mockups, and promotional material materials (as needed) to ensure compliance with regulations. Prepare and assemble regulatory submission dossiers for local authorities, related to new marketing authorizations and life cycle management as needed. Guarantee that legal and internal deadlines are met. Maintain systems updated (Veeva, among others), as well as physical archive as needed. 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 leadership experience is preferred;
• Knowledge and management of regulatory requirements/environment in Brazil and/or Peru required. Other LatAm countries is an asset;
• Knowledge of developing strategies & guidance and communicating to local, regional and global stakeholders to assure that all regulatory submissions are planned and executed as per regulatory and business requirements;
• Experience in perfoming pre- & post registration and life cycle management activities (including renewals, variations, labelling) to obtain approvals before the health authority;
• Excellent verbal and written communications skills, both in English & in Spanish. Knowledge of Portuguese is desirable.
• Proficiency in use of databases, excel, power point; Digital & AI knowledge is an asset.

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!