Financial Accountant (Swedish)March 29, 2021
Clinical Trial Start -Up Associate (Czech / Slovak)April 14, 2021
Purcelloleary Recruitment are looking to recruit a Regulatory Delivery Manager for a pharmaceutical company in Co. Cork. This is initially a REMOTE position; however, the successful candidate will be required on site when the company re-opens the building.
The Regulatory Delivery Excellence (RDE) Manager is responsible for the recruitment, retention and resource assignment of the regulatory associates managing submissions in the Global Regulatory Affairs (GRA) organization. The RDE Manager provides leadership, direction, as well as technical / process expertise to the regulatory associates responsible for the regulatory submission management process across the CTD modules. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives regulatory team collaboration to the achievement of goals and objectives.
- Recruit, develop, and retain a diverse and highly capable workforce
- Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making
- Ensure regulatory publisher competencies are present and continuously improving
- Support and encourage a culture of innovation and model inclusivity to ensure diverse
- Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution.
- Understand regulations and how they apply to the submission process and use this to provide technical leadership to the team
- Ensure strategies for enhancing focus on the customer exist and are implemented.
- Actively partner with upstream work units to ensure process alignment and best practices.
- Develop, implement, and monitor metrics to ensure continuous improvement and compliance.
- Partner with quality in both process improvements and deviation management.
- Bachelor’s Degree in a scientific or health-related field
- Fluent in English
- Minimum 5 years Regulatory Delivery experience in the pharmaceutical industry
- Must understand regulatory processes and the interdependencies of various tasks that require coordination among cross-functional team members and possibly third parties
- Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
- Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence
If you would like to discuss this role, please reach out to Louise Whitty on 083 4296073 / firstname.lastname@example.org