Purcelloleary have been assigned to recruit for the role of Regulatory Associate:
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
- Guide and influence development team and function regarding internal and Agency registration management processes and requirements
- Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurateRecords include:The IND and NDA submissionsTracking the status of pending applications and commitmentIncoming correspondence and records of contact
- Serve as the GRA-NA operational lead for registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings and GRACRR planning.
- 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
- Provide registration management expertise to the due diligence and business development processes.
- 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)
- Develop collaborative relationships with personnel in other functional areas (e.g. medical, legal, labeling, compliance, quality, affiliates, etc.) to effectively influence the electronic registration plan.
- 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.
- Influence others in a manner that creates maximum advantage for the organization.
- Communicate verbally and in writing to effectively influence within work group/function and with development team
- Serve as a mentor within GRA.
Requirements for the Regulatory Associate
- A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.