Lilly Regulatory Associate CMC in Cork, Ireland
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.
Eli Lilly – Cork GBS
At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 750 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 44 nationalities.
Established in 2010 to gain efficiencies in areas such as General Accounting, Purchase to Pay and Order to Cash, the GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions including Customer Meeting Services, Global HR Data Management, Medical Information, Procurement, Trial Capabilities and more to come on stream across 2019 and 2020.
Eli Lilly - GRA CMC
GRA - Chemistry, Manufacturing, and Control (CMC) is responsible for regulatory strategy, submissions and regulator interactions associated with all products in development up to and including initial market applications in all countries around the globe. GRA-CMC is also responsible for the regulatory strategy and post approval submissions for Commercial Products to ensure reliable supply and continuous improvements. This includes small molecules, biotechnology, Insulin products, devices, and drug / device combination products.
We work in collaboration with other areas of GRA, Product Research & Development, Technical Services / Manufacturing Sciences, Quality, Product Delivery PM, PPM, and PDS to develop CMC regulatory strategies, provide regulatory risk assessments, and implement regulatory processes to support products and CMC teams.
To be Industry Leading in Application of CMC Regulatory Science, Leveraging Quality by Design to Obtain Timely Approvals that Enable Continuous Improvements in Product Quality and Manufacturing Processes.
The Global Regulatory Affairs group at Eli Lilly is growing. We are looking for an associate to lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. Are you ready to embark on the next step in your career? Do you have experience in regulatory submission or similar function? This exciting opportunity will enable you to utilize your project management and communication skills to advance the submission process for new molecules. You will also partner with GRA-CMC Scientists to help build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions. You will work within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working understanding of internal procedures, guidances and regulatory precedence. You will triage and lead the communications between our Lilly Affiliates, GRA-CMC Scientists, and Specialists. You will be the point person for communication regarding submission tracking requirements to both GRA-CMC Scientists and internal customers. Are you willing to lead efforts around global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support? We need your expertise.
Regulatory & Drug Development Expertise
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 guidances 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.
Lead, Influence, Partner
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)
Knowledge of pharmaceutical drug development or industry-related experience preferred.
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
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
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!