- BBBH772956 Jan 08, 2021 Competitive
Clinical & Regulatory Associate required to join one of Cork's leading companies as part of this exciting new project. See below for more information.
I am delighted to be recruiting for this role, along with many other Regulatory and Clinical roles in one of Cork's leading pharmaceuticals. For more information on this role, or other roles that have been released as part of this project, please contact me, Julieann, at firstname.lastname@example.org for more information. You won't want to miss these opportunities.
The purpose of the Clinical - Regulatory Associate is to be 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 the company, 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. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this associate embrace corporate transformation initiatives and represent Global Regulatory Affairs 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. 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 accurate. Records include: The IND and NDA submissions. Tracking the status of pending applications and commitment, Incoming correspondence and records of contact
- Serve as the operational lead for registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings and 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 the team that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutions.
- 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
Minimum Qualification Requirements:
- A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
353 (0) 21 2300300