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 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 role of Associate Director- GRA Regional Regulatory is to provide regional regulatory expertise and strategy, ensuring integration with other functional areas within the Regional Management Team. This role required technical regulatory expertise, a comprehensive understanding of the company’s product portfolio, and effective collaboration with corporate teams, regional affiliates and external business partners. This position is crucial in aligning regulatory activities with both local and global standards to support our business objectives.
Regulatory Compliance:
- Lead the implementation of Good Regulatory Practices/Regulatory Quality expectations at the regional/affiliate level.
- Lead targeted process initiatives in support of regulatory and quality system compliance.
- Support and ensure the affiliate practices are aligned with external requirements and internal regulatory quality expectations.
- Provide affiliate process consultation to corporate regulatory management and other regulatory functional support groups
- Regional regulatory coordination cross-functionally on regulatory compliance projects
- Support risk assessment and risk management for regional regulatory activities with compliance impact including the planning and execution of external partnerships.
Regulatory Operations and Business Support:
- Provide guidance/training in the management of Regulatory tools and associated regulatory business processes.
- Coordinate the integration of regional business priorities, product issues and business development initiatives impacting affiliate and regional regulatory.
- Drive regulatory submission strategies and coordinate the alignment of region/country regulatory and business plans.
- On-board new regulatory employees in the region independently from reporting lines and provide ongoing coaching to affiliate regulatory staff
- Develop regional strategies and plans for regulatory professional development including, training programs, Reward and Recognition programs, affiliate and regional regulatory career path development.
- Continual assessment of needs and capabilities of affiliates/alliance regulatory professionals.
- Develop recommendations to Global Regulatory Affairs and/or affiliate management regarding resource needs and gap analysis.
Regulatory Professionals:
- On-board new regulatory employees and provide ongoing coaching to affiliate regulatory personnel
- Lead change management processes and provide training during implementation of regulatory initiatives
- Develop regional strategies and plans for regulatory professional development (e.g., training programs, reward and recognition programs, affiliate and regional regulatory career development)
- Coordinate regional regulatory meetings agendas to ensure effective linkages of business activities and communications to improve employee engagement.
Alliance Management:
- Support the development of Product Registration Agreement between Lilly and external partner and monitor the agreement execution by the external partner and as needed perform escalation and develop gap closure strategies.
- Strategy development and execution for marketing authorization transfers from Lilly to the partner
- Support the Partner in regulatory planning and plan execution for new products, new indications, line extensions and ensure internal cross-functional alignment
- Intervene to remove barriers as needed to ensure timely provision of support to the partner in line with the agreed timelines for new and maintenance activities
- Support external and internal audits, assessments & self-inspections.
- Ensure strong working relationship with Alliance Partner(s) and effectively manage disagreements as needed.
- Manage internal and external stakeholders understanding and expectations in supporting Alliance Partnership
Minimum Qualification Requirements:
- Education: BS in pharmacy, chemistry, biology, pharmacology, or related science
- Good knowledge of written and spoken English.
- Has acquired some administrative skills to organize projects and get proposals evaluated on a global basis.
- Negotiation skills to allow forward movement of projects.
- Ability to work with multiple projects and handle multiple priorities.
Other Information/Additional Preferences:
- Excellent communication skills: verbal, writing, presenting, listening.
- Interpersonal and teamwork skills to allow effective teambuilding across diverse global organizations.
- Focus on detail, accuracy, and organization.
- Familiarity or comfort with cultural diversity.
- Creative thinking and problem-solving skills. Ability to find solutions for complex technical issues.
- Strong knowledge of quality systems.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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