LOCATION: CORK, IRELAND (FUNDED RELOCATION PACKAGE AVAILABLE)
The purpose of the The Associate, GRA-NA, is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients. This is accomplished through a strong working knowledge of regulations, guidance’s and regulatory precedence and collegial and mutually productive relationships across company's components, partner companies, and within relevant ministries of health. The Associate utilizes process expertise and therapeutic area knowledge to drive appropriate internal consistency, and influence effective change management within GRA and cross-functionally. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embrace corporate transformation initiatives and represent Global Regulatory Affairs-NA (GRA-NA) as a change ambassador.
Provide Regulatory & Drug Development Expertise
- Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for GRA-NA. This includes but us not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD.
- Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification
- Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate. Records include: The IND and NDA submissions. Tracking the status of pending applications and commitment. Incoming correspondence and records of contact
- Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions.
- Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
- Serve as the registration management expert for other processes dependent upon the registration record (e.g. OSI requests, out-license, user fees/drug listing/orange book)
- Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutions.
- Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review
- Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings.
- Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise.
- Serve as a mentor within GRA.
Minimum Qualification Requirements:
- A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.
Other Information/Additional Preferences:
- Industry-related experience
- Knowledge of drug development process, regulatory/business strategies and plans
- Demonstrated ability operate and manage operational requirements in a highly regulated environment
- Demonstrated effective written, spoken and presentation communication
- Demonstrated effective negotiation and influence skills
- Demonstrated attention to detail
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Permanent, Full Time
Additional Salary Info
- Industry Sector Health, Nursing