Associate / Sr. Associate - Regulatory Cmc, Regulatory Delivery Excellence (Rde)

Overview
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 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 put people first and seek colleagues determined to make life better for people around the world.
Eli Lilly Cork is a diverse team of over 2000 employees across 60 nationalities delivering innovative solutions across Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Cork offers a premium campus workspace with flexible hybrid working, healthcare, pension and life assurance, subsidised canteen, onsite gym, travel subsidies and on-site parking.
Inhouse People Development services and wellbeing initiatives are part of the benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI) across all dimensions, with pillars EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
EnAble partners with the Access Lilly initiative to promote an accessible and inclusive environment for all.
Come join our team — Be Creative, Be an Innovator, and Be Yourself
Purpose
The Associate, Regulatory CMC, 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 submission content, provide guidance on structure and content placement within CTD registration submissions, and assist 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, leveraging internal procedures, guidance and regulatory precedence.
The Associate triages and manages communications between Lilly Affiliates, GRA-CMC Scientists, Specialists, and Quality/Reg Representatives.
The role uses GRA-CMC submission process expertise and IT tools to develop project management expectations across projects.
Based on implementation and supply chain needs, the Associate will communicate submission tracking requirements to internal customers.
The scope includes global regulatory requirement assessment, strategy development, coordination of submissions with submission specialists, and project management for marketed product support.
Primary Responsibilities:
The job description provides a general overview of requirements and may change over time.
Consult with supervision regarding actual responsibilities and related duties.
Regulatory & Drug Development Expertise
Lead CMC submission management with knowledge of CMC regulatory requirements, ICH CTD, evolving global agency standards, CMC RA submission processes, electronic submission regulations and CTD structure guidance; provide this to CMC development teams for global CTAs and registration dossiers; prepare CMC CTD content aligned with manufacturing changes and reports.
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 execution of submission planning for global registration and maintenance submissions.
Triage Lilly affiliate inquiries and, when needed, consult with the CMC RA Scientist to prepare responses.
Interpret global regulations and guidance and align submission processes and publishing standards with local regulatory requirements; collaborate with Lilly affiliate regulatory staff to establish new submission standards as needed.
Lead, Influence, Partner
Foster an open discussion environment across Global Regulatory and CMC development teams to reach robust project decisions; challenge teams constructively to achieve best solutions.
Use internal forums to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission requirements.
Communicate effectively to guide and influence within the team and with development partners regarding lifecycle management processes.
Demonstrate strong problem-solving skills and the ability to address regulatory issues across functions and geographies.
Minimum Qualification Requirements
Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related field).
Knowledge of pharmaceutical drug development or industry-related experience preferred.
Other Information / Additional Preferences
Drug development process or industry-related experience.
Knowledge of agency submission procedures and standards; awareness of emerging electronic submission standards.
Ability to operate and manage regulatory-compliant operational requirements.
Strong written, oral, and presentation skills.
Negotiation and influence skills.
Attention to detail and ability to prioritize effectively.
Proven effective teamwork skills and ability to adapt to diverse interpersonal styles.
Lilly is dedicated to helping individuals with disabilities engage in the workforce and providing equal opportunities for all applicants.
If you require accommodation to submit a resume, please complete the accommodation request form at the following link for further assistance.
This is for accommodation requests as part of the application process.
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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