CMC Development Manager -RDE
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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. The RDE Manager leads the regulatory associates responsible for the execution and delivery of submissions to global health authorities. The RDE Manager supports execution of the submission plans that are aligned with the molecule team. To achieve this goal, the RDE Manager uses their regulatory and submission expertise, a strong working knowledge of customers, internal procedures, guidances and regulatory precedence.
Primary Responsibilities: 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.
- 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
- 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:
- 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
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-19255.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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