Associate Director, Regulatory Submissions

As a Senior Regulatory Affairs Associate you will have the opportunity to work within Regulatory Authority Submissions related to Clinical Trials, supporting many projects in Brazil. Previous experience submitting clinical trials to ANVISA is required. Responsible for quality deliverables at the country level; follows project requirements and applicable...

**HOW MIGHT YOU DEFY IMAGINATION?**If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

The Junior Associate assists in the assembling of submissions (low complexity post-approval changes in CTD or non-CTD format such as leaflet and packaging notification, administrative changes, renewals, support with Annual Reports activities, support with CMC changes and GMP Renewals for vaccines, biological products and small molecules) and delivery of...

Direct all Regulatory Affairs activities within the respective country(ies).As Head of LATAM, Manage and oversee assigned Regulatory Affairs activities within Brazil, South Latin America and other Latin America Countries and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of...

We are seeking an Associate Scientist to join our team in supporting regional Chemistry, Manufacturing and Control (CMC) strategy, the preparation of documentation, and the execution of regional post-approval submissions and new product registrations. In this role, you will serve as a vital link between Regional and Local Regulatory Affairs and Product...

Overview At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

Working with UsChallenging.Meaningful.Life-changing.Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

**Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...