Regional Regulatory Affairs Manager

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**

In your role as Cluster Manager, you will lead and manage all operational Life Cycle Management activities across designated countries and therapeutic areas. This includes providing strategic guidance and planning, supporting in the development of regulatory strategies, follow up of regulatory activities to guarantee that legal and internal deadlines are met and all the post approval activities until implementation, according with the deadlines. Coordinating efforts across countries and portfolios, facilitating interactions with Health Authorities and Trade Associations, and ensuring the effective implementation of roll-out plans that are fully aligned with the company’s overall strategy.You will ensure compliance with Health Authority requirements and internal guidance/procedures while fostering close collaboration with the Regulatory Affairs Head and the CRA team to achieve business objectives.As a Manager, you will lead a team of Regulatory Coordinators, setting commitments, providing coaching, focusing in development and ensuring high performance within your team. You will build and align processes globally, regionally, and locally, utilizing agile working methods to enhance operational efficiency. You will identify and implement continuous improvement practices to increase output, reduce backlogs, and address critical technical and organizational challenges. Your role will also involve conducting data-driven analyses to develop improvements and enhance data visualization in communications with senior leaders and stakeholders. Effective relationship management and fluent communication with cross-functional stakeholders will be essential as you identify and resolve critical issues while escalating risks when necessary.

**Who You Are**
- Degree in Pharmaceutical chemistry, Biochemical chemist or other Life Science degree.
- Over 6 years of experience in regulatory affairs in pharmaceutical industry managing biotechnological and/ or RX-synthetic portfolios, including Latam expertise in post-marketing regulatory activities, with demonstrable experience in Mexico; South Cone experience is an asset.
- At least 3 years of experience in leading a high-performance team, setting strategic direction, and fostering accountability and alignment with organizational goals.
- 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 performing pre
- & post registration and life cycle management activities (including renewals, variations, labelling) to obtain approvals before the health authority;
- Strong project leadership skills with international experience; competent in managing timelines, deliverables, and associated budgets. Effective in balancing multiple initiatives simultaneously, meeting deadlines while maintaining high-quality output.
- Demonstrated ability to manage competing priorities and deliver results in high-pressure, fast-paced environments.
- Proven ability to work collaboratively within cross-functional, multicultural teams. Willingness and availability to travel internationally at least once per year.
- Exceptional verbal and written communication skills in English; Portuguese proficiency is considered an asset.
- 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 believe that this variety 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 w