Associate/Snr Associate - Regulatory Activities, PK/PD

Associate/Snr Associate - Regulatory Activities, PK/PD

Eli Lilly Benelux

Cork, Ireland

As a PK/PD Regulatory Activities Coordinator, you will be responsible for assisting with PKPD regulatory tasks related to the submission of medicines to global regulatory authorities. You will apply your knowledge of global regulatory guidelines, clinical trial data reporting (early and late phase), and PK/PD knowledge to advise and support PKPD scientists on required deliverables. You will work closely with PK/PD scientists and cross-functional teams to oversee key PK/PD deliverables, ensuring high quality and on-time delivery.

Primary Responsibilities:

Regulatory Expertise:

• Familiarity with global regulatory requirements for each region;
• Advise PK/PD Scientists on requirements to support submission deliverables;
• Assist on packaging submission deliverables and regulatory responses;
• Coordinate PK/PD deliverables with Global Regulatory Affairs Regulatory Scientists;
• Develop critical product registration timelines and electronic submission structure and content requirements.

PK/PD scientific and technical knowledge:

• Understanding of PK/PD analyses, data reporting and dataset requirements, and common technical documents for submissions;
• Collaborate with data management teams to ensure accurate collection, processing, delivery and analysis of PK/PD data, adhering to established standards;
• Contribute to process improvement initiatives to enhance efficiency, leveraging best practices, and innovative approaches;
• Collaborate with cross-functional teams to deliver submission documents.

Minimum Requirements:

• BSc in relevant scientific field, such as biological/pharmaceutical sciences, chemistry, engineering, statistics, data science or health-related discipline;
• Understanding of Pharmacokinetics/Pharmacodynamics principles;
• Regulatory experience in a pharmaceutical or biotech setting.

Additional skills/preferences criteria

• Knowledge of regulatory and compliance guidelines;
• Understanding of clinical pharmacology (PK, PD and pharmacometrics) principles;
• Knowledge of Clinical Quality work processes and GCP compliance;
• Excellent organizational and time management skills;
• Proven ability to work independently and adapt to evolving priorities in a fast-paced environment;
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.

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