About Optum
We are a global organisation that delivers care, aided by technology to help millions of people live healthier lives. Our work directly improves health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best.
Our Culture
Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. We advance health equity on a global scale, making a positive impact on the communities we serve.
Innovation at Optum
In healthcare, evolution doesn't just happen. It takes innovation, imagination, and a passion for solving problems in new and better ways. And innovation is taking place at a lightning-fast pace every day at Optum.
A Career with Purpose
We're expanding our team in Ireland and creating excellent opportunities for those who want greater purpose and more impact in their work. You'll have access to investment, support, and resources to advance your career.
Regulatory Affairs Director Role
This role offers the unique opportunity to be at the forefront of something new, where your contributions will directly shape the future direction and success of the business. As a Regulatory Affairs Director, you'll oversee and manage Pharmacovigilance activities and drug safety processes.
Responsibilities
* Support design and implementation of regulatory strategies for a new service line; ensure compliance with local and international regulations, including FDA, EMA, and other relevant regulatory agencies
* Ensure adherence to all applicable regulatory requirements for license and labels, including FDA, EMA, Wholesale Distribution Authorization (WDA), and other relevant authorities
* Coordinate and manage the preparation, submission, and tracking of licensure applications, ensuring completeness, accuracy, and timeliness
* Oversee and manage the Pharmacovigilance (PV) activities to ensure all adverse events are recorded, processed and reported in alignment with the timelines agreed with manufacturing business partners
* Oversee and manage Pharmacovigilance activities to ensure all processes related to drug safety are effectively managed, recorded, processed and reported to manufacturers partners
* Collaborate with manufacturer partners and work closely with pharmaceutical companies to monitor drug safety.
Requirements
* Bachelor's Degree (or higher) in pharmaceutical or life sciences industry
* Proven experience in licensure support within the pharmaceutical or life sciences industry
* Knowledge of regulatory requirements and guidelines related to licensure support, including FDA and EMA labeling guidelines including labeler code registrations, Distribution Practices (GDP) and Wholesale Distribution Authorization EU rules and regulations
* Familiarity with abbreviated new drug and biosimilar applications
Benefits
Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny office and telecommuting from a home-based office in a hybrid work model.