Job Description
Regulatory Affairs Director Opportunity
Optum, a Fortune Global top 10 business, 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.
Key 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 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
Requirements:
- Proven experience in licensure support (or bachelor's equivalent) within the pharmaceutical or life sciences industry
- Strong knowledge of regulatory requirements and guidelines related to licensure support, including FDA and EMA labeling guidelines including labeler code registrations (NDC), Good Distribution Practices (GDP) and Wholesale Distribution Authorization EU rules and regulations
- Familiarity with abbreviated new drug and biosimilar applications
- Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively
- Attention to detail and accuracy in documentation and record-keeping
- Strong 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
- Proficiency in using relevant software applications and tools for documentation management and project tracking
Preferred Qualifications:
- Demonstrated intermediate-expert level of knowledge or 2-5 years of experience in health care policies, procedures, and documentation standards
- Demonstrated intermediate-expert level of knowledge or 2-5 years of experience in developing licensure strategies
- Experience in helping organizations apply for and procure licenses such as the Wholesale Distribution Authorization (WDA)
Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. 2024 Optum Services (Ireland) Limited. All rights reserved.