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Purpose: The Cork CMC Regulatory Scientist leads, in partnership with the GRA-CMC Regulatory Scientist, the various aspects of global marketing authorization submission management processes. The Cork CMC Regulatory Scientist partners with GRA-CMC Regulatory Scientist to help manage submission content for Drug Substance and Drug Product, 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 Cork CMC Regulatory Scientist provides tactical and operational direction to expedite CMC development of Lilly's portfolio and technical agenda by supporting market registration submissions, and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes.
The Cork CMC Regulatory Scientist is responsible for networking with RDE CMC Regulatory Associates to ensure proper communication and adherence to workflows to deliver on time product lifecycle management.
Primary Responsibilities: Regulatory Expertise
Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizations.Partner with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers.Ensure successful preparation of CMC dossiers and variation packages to support product submissions.Provide regulatory leadership and support for products listed as the primary responsibilities.Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as TS/MS (process and technology transfers), manufacturing, quality control and quality assurance.Be a responsible party for preparing CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.Partner with the GRA-CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes for content reuse for the Rest of the World countries.Manage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing, clinical teams), monitor approval status and communicate change status to interested personnel in a timely manner.Partner with RDE CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product & site renewals as well as license expiry, where applicable.Manage authoring and content reviews of simple RtQs.In conjunction with RDE CMC Regulatory Associates and GRA-CMC Regulatory Scientists, may be involved in the management of some GMP documents, if applicable.Review/Approve regulatory documents such as: full and core CMC Dossiers, variation packages, post-approval commitments with health authorities and answers to questions received from health authorities.Lead, Influence, Partner
Create an environment within the Global Regulatory Area and across CMC 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 expertise to meet critical product registration timelines and electronic submission structure and content requirements.Communicate effectively to guide and influence within work group/function regarding life-cycle management processes.Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies.Minimum Qualification Requirements: Minimum a college degree (BSc), ideally an advanced degree (MSc, PhD, PharmD preferred), in related biological and life science field.The applicant should have solid regulatory experience in either a pharmaceutical or biotech setting.Strong knowledge of regulatory and compliance guidelines within pharmaceuticals / biopharmaceuticals.Strong knowledge of Manufacturing & Quality work processes as well as GMP compliance.Proven ability to effectively influence within and beyond the GRA organization.Communicates effectively, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.Displays conscientious attitude, and possesses excellent verbal and written communication skills.Fully proficient in RIM and in using common Microsoft applications to create and present work.Good organizational skills, with the ability to prioritize and be self-motivating.Work well collaboratively within a team, or as an individual contributor.Possesses excellent attention to detail and ability to effectively prioritize.Proven effective teamwork skills; Able to adapt to diverse interpersonal styles.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.
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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