Associate Director/Director, GRA-CMCD Diagnostics Regulatory Scientist - IVD Studies and Clinical Trial Support

Associate Director/Director, GRA-CMCD Diagnostics Regulatory Scientist - IVD Studies and Clinical Trial Support

Eli Lilly Benelux

Cork, Ireland

Purpose:

The GRA-CMC & Devices IVD Performance Studies & IVD Trial Support Regulatory Scientist is accountable for assessing, establishing and operationalizing the regulatory strategy and execution plan for assigned IVD performance studies and for clinical trials that use IVDs, ensuring that study conduct and IVD use are compliant with the EU IVDR (primary region) and/or applicable national requirements. The IVD Performance Studies and Trial Support Regulatory Manager may support IVD performance studies and Clinical Trial Applications (CTAs) in multiple geographies. These activities are accomplished with a strong working knowledge of regulations, guidelines, and regulatory precedence, coupled with a strong knowledge of in vitro diagnostic development. To accomplish this purpose, it is necessary for the Regulatory Scientist to develop collegial and mutually productive relationships across Lilly LRLfunctions, partner companies, and health authorities.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Performance Study Applications:

• Ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries assigned responsibility (e.g. US, EU, Canada &/or other international countries).
• Co-ordinate and lead the Performance Study Application (PSA) Kick-Off Meeting.
• Determines and communicates submission and approval requirements and regulator expectations
• Generates regulatory documents/content for Lilly led submissions and/or review IVD partner submissions to ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate scientific position.
• For Lilly developed IVDs, work with CDL and Quality to develop and compile technical file documentation.
• Support and/or lead interactions with regulatory agencies.
• Support high quality regulatory responses in partnership with appropriate team members.
• Communicate key milestones to the Project team, including tracking and documentation in appropriate systems.
• Ensure coordination with Third Party Operations.

Modifications/Trial Maintenance:

• Play an active role in strategic decisions around submission of modifications in partnership with Trial Capabilities and the Project team.
• Prepare & review submission documents in accordance with local requirements and ensure accuracy of submission package to minimise any errors before submissions.
• Support high quality regulatory responses in partnership with appropriate team members.
• Communicate key milestones to the Project team, including tracking and documentation in appropriate systems.
• Ensure coordination with Third Party Operations.

Regulatory Expertise for Performance Studies & IVDs used in Clinical Trials in the Region:

• Advise the team on regulatory strategy for IVDs used in clinical trials.
• Review documents from Third Parties to ensure regulatory compliance and enable IVDs use in clinical trials.
• Provide up-to-date expertise on performance study and clinical trial regulations and guidelines.
• Ensure compliance with all applicable regulations and internal quality systems.
• Interpret and anticipate impact of new guidelines and initiate change in response to changing environment.
• Identify and communicate internal and external trends. Incorporate these insights into internal strategies.

Lead, influence and partner:

• Support the implementation of IVDR centre of excellence with a cross-functional team.
• In partnership with the Senior Director, lead the resolution of development and regulatory issues impacting clinical trials.
• Participate in forums that share IVDs and performance studies information & expertise across GRA and other Lilly teams and business partners.
• Propose and lead continuous improvement projects to simplify performance study processes and increase efficiencies.
• Represent the regulatory function on cross-functional performance study or clinical trial-related projects.
• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
• Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Constructively challenge teams to reach the best solutions to issues.
• Create and lead in an environment of equity and inclusion that encourages open discussions on issues to achieve a robust outcome on business decisions.

Minimum Qualification Requirements:

• Bachelor’s degree in scientific or health sciences discipline.
• Fluency in English.
• Deep understanding and knowledge of in vitro diagnostic regulations and procedures for primary region.
• Minimum of 3 years of diagnostic regulatory experience and/or 7 years’ experience in diagnostics development with regulatory affairs exposure and/or 3 years of medicines clinical trial experience.
• Ability to assess and propose ways to manage risk in a highly regulated environment.
• Ability to Influence complex regulatory issues within the function and across disciplines through technical and/or regulatory expertise.
• Effectively defend BU/IBU perspective within team.
• Lead teams to resolve regulatory issues with minimal supervision and ability to guide teams through multiple development stages.
• Familiarity and openness towards cultural diversity. Embraces different styles of working.
• Demonstrated ability to effectively work independently and in a team.
• Knowledge of the drug development process.

Other Information/Additional Preferences:

• Knowledge of local/regional regulatory procedures and practices, particularly related to EU performance studies, medical device investigations or clinical trial applications.
• Previous Regulatory Affairs or Clinical Trial experience.