Optum is a global organisation that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.
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.
As the fastest growing part of the UnitedHealth Group family of businesses, we’re expanding our team in Ireland and creating excellent opportunities for those who want greater purpose and more impact in their work. We’ll provide the investment, support, and resources to advance your career. You’ll provide the talent, ambition, and drive.
As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals.
With a strong ecosystem of investment and innovation, our business in Ireland is constantly growing to support the healthcare needs of the future. We are excited to introduce a new service line within the Optum network, focused on biosimilar commercialization. This initiative represents a significant step forward in our commitment to delivering high-quality healthcare and pharma solutions. 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. You’ll enjoy the benefits of working within a well-established company while also experiencing the excitement, agility, and innovation typically found in a new venture.
Optum is seeking a detail-oriented and highly organized individual to join our team as a Regulatory Affairs Director. This role is for a new service line within the Optum network and will work closely with cross-functional teams to facilitate the timely and accurate submission of licensure applications and maintain ongoing compliance throughout the licensure process. The role is to oversee and manage Pharmacovigilance activities and drug safety processes.
Schedule: Full-time position with standard working hours of Monday – Friday, 9am – 5pm. Please Note: you must be able to work onsite in office for a minimum of 3 days per week REQUIRED with flexibility to work 4 days per week when needed.
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.

REQUIRED QUALIFICATIONS:

• 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
• Intermediate level of proficiency in using relevant software applications and tools for documentation management and project tracking

PREFERRED QUALIFICATIONS:

• Demonstrated intermediate level of knowledge and experience in health care policies, procedures, and documentation standards
• Demonstrated intermediate level of knowledge and experience in developing licensure strategies
• Experience in conducting/managing Pharmacovigilance activities
• Experience in helping organizations apply for and procure licenses such as the Wholesale Distribution Authorization (WDA)

SOFT SKILLS:

• Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively
• Attention to detail and accuracy in documentation and record-keeping
• Communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders
• Ability to work independently and proactively while taking ownership of regulatory support activities

• 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.
• Oversee and manage the preparation and submission of regulatory documentation for any product labeling requirements
• Provide guidance and support to project teams regarding regulatory requirements and potential risks and mitigation strategies.
• Support team of regulatory professionals, both domestic and global, facilitating regulatory adherence, maintaining documentation, and meeting any authorization renewal requirements
• Maintain an organized and up-to-date repository of all licensure-related documentation, including licenses, permits, certificates, and other relevant records
• Stay informed about changes in regulatory requirements and guidelines related to licensure support and ensure timely implementation of any necessary updates or modifications
• Identify potential risks and develop strategies to mitigate them, ensuring that regulatory activities are conducted in a manner that minimizes regulatory and compliance risks
• Proactively identify opportunities for process optimization and efficiency enhancements within the regulatory function, implementing appropriate measures to drive continuous improvement
• Ability to manage at least 1 direct report
  You will be rewarded and recognised for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role, as well as providing development for other roles you may be interested in.