- Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
- Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
- Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
- Responsible for triage of Lilly affiliate inquires and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
- Implement and in some cases interpret global regulations and guidance's and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Lilly affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.
- Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
- Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
- Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes
- Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies
- Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)
- Minimum of 2 years previous regulatory submission experience.
- Drug development process or Industry-related experience
- Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.
- Ability to operate and manage operational requirements in a regulated environment
- Written, spoken and presentation skills
- Negotiation and influence skills
- Attention to detail and ability to effectively prioritize
- Proven effective teamwork skills; able to adapt to diverse interpersonal styles
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Global CMC Regulatory Associate, Regulatory Delivery Excellence - Indianapolis, United States - Eli Lilly
Description
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.
Organization Overview:
The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE) leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Associate also partners with GRA-CMC Scientists to help create and manage RIM/Leo/Regulus submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions. The Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidance's, and regulatory precedence. The Associate will triage and manage the communications between our Lilly Affiliates, GRA-CMC Scientists, Specialists, and the Quality/ Reg Representatives. The Associate utilizes GRA-CMC submission process expertise and their expertise with Information Technology tools to develop project management expectations across projects. Based on implementation and supply chain needs within manufacturing, the Associate will be responsible for routine communication of submission tracking requirements to both GRA-CMC Scientists and internal customers. The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support.
Responsibilities::
Regulatory & Drug Development Expertise
Lead, Influence, Partner
Basic Requirements:
Additional Skills/Preferences:
Additional Information:
• Travel less than 5%
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 ( ) 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 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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