Regulatory Coordinator

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

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 Role**:
Taking part in the Regulatory Uruguay Hub, the main objective of the position is to provide support to the US Regulatory strategy team for label development and labeling maintenance including:

- Assist US Regulatory Lead on the development of Prior Approval Supplement (PASs) for NDA to BLA transition.
- Conduct Quality Control activities of artworks.
- Implement product labeling update in final artwork.
- Manage single source of labels (Company websites, Veritas etc.).
- Update systems and websites as needed with FDA approval label, release note to all stakeholders.
- Create templates required for comprehensive reports (keeping track of label-changes).
- Manage the development of the SPL (Structured Product Labeling) version by closely working with external vendors to generate them (vendor oversight).
- Provide support for various post-approval activities involving US labeling updates including submission to Daily Med and responses to FDA.
- Interact with Regulatory Affairs colleagues and cross-functionally with global members of the Clinical, Medical, Legal, Safety, Commercial, Quality and Supply Chain organizations to support all labeling activities.
- Coordinate with US Regulatory Lead and REC labeling team to ensure approved label artwork is initiated and changes tracked.

**Who You Are**:

- Bachelor's Degree in a Life Science or related discipline with 1 to 3 years of working experience.
- Excellent spoken & written English skills are a must.
- Quick ability to adopt digital and technology tools & concepts.
- Regulatory experience and/or knowledge in US Regulation and/or US labelling/artwork processes is strongly preferred.
- Experience in projects/vendors management including close interaction with diverse stakeholders is strongly preferred.
- Experience with artwork & label creation (WebCenter) and Veeva Vault promo material is strongly preferred.

**What we offer**:With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life

Job Requisition ID: 244276

Location: Montevideo

Career Level: C - Professional (1-3 years)

Working time model:
**Careers during Covid-19**
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone's health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

**North America Disclosure**

**Notice on Fraudulent Job Offers**
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.

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