Job Description
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Regulatory Scientist Role
Eli Lilly Cork is a global healthcare leader based in Indianapolis, Indiana. Our employees around the world work together to discover and bring life-changing medicines to those who need them. We improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
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Key Responsibilities
The Regulatory Scientist will provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain and maintain marketing authorizations. The role involves partnering with GRA-CMC Regulatory Scientists to manage outsourcing activities and contract manufacturers.
The successful candidate will ensure the preparation of CMC dossiers and variation packages to support product submissions. They will provide regulatory leadership and support for products listed as primary responsibilities, develop and execute regulatory strategies, and plan and prepare submission content for marketed products.
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Requirements
* Minimum a college degree (BSc), ideally an advanced degree (MSc, PhD, PharmD preferred), in related biological and life science field.
* Solid regulatory experience in either a pharmaceutical or biotech setting.
* Strong knowledge of regulatory and compliance guidelines within pharmaceuticals / bio-pharmaceuticals.
* Strong knowledge of Manufacturing & Quality work processes as well as GMP compliance.
* Proven ability to effectively influence within and beyond the GRA organization.
* Excellent verbal and written communication skills.
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Benefits
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and wellbeing initiatives enhance the career experience for our colleagues.
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Additional Information
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. 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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