German Medical Information AgentJune 28, 2021
QA EngineerAugust 11, 2021
Job Description : Regulatory Delivery
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.
Primary Responsibilities: Regulatory Delivery
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
People Management: Regulatory Delivery
- Recruit, develop, and retain a diverse and highly capable workforce
- 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
- Demonstrate strong business acumen, problem-solving skills, and learning agility to help teams plan for contingencies, and adjust to change
- 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
- Utilize regulatory and process knowledge to drive decision-making
- 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.
- Monitor regulation/external environment as appropriate
Effective Management for the Regulatory Delivery
- 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
- Provide resources for area strategic initiatives and process improvements.
- Proactively seeks feedback on team’s performance for continuous learning
Minimum Qualification Requirements Regulatory Delivery:
- Bachelors Degree, preferably in a scientific or health-related field
- Fluent in English, verbal and written
- Previous 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
- Strong communication skills; able to communicate clearly and succinctly with team members and leadership
- Ability to embrace the diversity of thought to model innovative behaviors (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
- Able to influence others without direct authority
- Travel may be required