Senior Manager – Regulatory Delivery Excellence

Cork, Ireland (hybrid)

The Regulatory Delivery Excellence (RDE) Sr. 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 Sr. 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. The RDE Sr. Manager leads the regulatory associates responsible for the execution and delivery of submissions to global health authorities. The RDE Sr. Manager supports execution of the submission plans that are aligned with the molecule team. To achieve this goal, the RDE Sr. Manager uses their regulatory and submission expertise, a strong working knowledge of customers, internal procedures, guidance’s and regulatory precedence.

Primary Responsibilities:

▪ Ensure robust individual training plans and timely completion of required training for direct reports

▪ 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

▪ Manage workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies

▪ Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered

▪ Understand regulations and how they apply to the submission process and use this to provide technical leadership to the team

▪ Utilize regulatory and process knowledge to drive decision-making

▪ Partner with quality in both process improvements and deviation management

▪ Monitor regulation/external environment as appropriate

▪ Align resources based on portfolio prioritization while demonstrating flexibility across business units and geographies

▪ Ensure a compliance culture and state of inspection readiness

▪ Model judgement-based decision making to navigate compliance and quality requirements

▪ Responsible for continuous improvement and shared learning and collaborates with process owners in the spirit of streamlining, efficiency, and effectiveness of submission management

▪ Proactively seeks feedback on team’s performance for continuous learning

Minimum Qualification Requirements:

▪ Bachelor’s Degree, preferably in a scientific or health-related field

▪ Previous experience in the pharmaceutical industry

▪ Ability to embrace the diversity of thought to model innovative behaviours (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)

Other Information/Additional Preferences:

• Prior experience in working with external business partners (e.g., CRO, Alliance, Joint Venture)
• Conflict management/conflict resolution skills