Regional Regulatory Start-Up Lead

Novotech; Poland; On-site; PLN 260,000 - 340,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Ongoing professional development and培训

Mentoring and career development

Collaborative global environment

Job summary

Novotech is seeking a Regulatory Start Up Manager in Poland to lead regulatory start-up activities across regions, aligning with the project manager to meet timelines and client expectations. You will develop RSU strategies, manage document customization, ensure submissions to health authorities, and coordinate with local teams to deliver on scope while maintaining regulatory compliance.

Join a global CRO offering flexible working options, ongoing professional development, and a collaborative,

Qualifications

• Graduate in a clinical, pharmacy or life sciences field.
• 3+ years CRO/pharma start-up/regulatory operations experience.
• Thorough knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• High proficiency in English.

Responsibilities

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with RSU strategy.
• Coordinate with local regulatory start up teams to deliver the agreed project scope on time and in compliance with the RSU plan.
• Oversee submission processes to health authorities and ethics committees; coordinate approvals regionally.
• Maintain CTMS and regulatory databases; provide progress updates to project manager.
• Deliver presentations and training to clients and stakeholders about regulatory start up activities.

Skills

Regulatory knowledge

Matrix management

Decision-making

Presentation skills

English proficiency

Education

Life sciences degree

Job description

Novotech is seeking a Regulatory Start Up Manager in Poland to lead regulatory start-up activities across regions, aligning with the project manager to meet timelines and client expectations. You will develop RSU strategies, manage document customization, ensure submissions to health authorities, and coordinate with local teams to deliver on scope while maintaining regulatory compliance.

Join a global CRO offering flexible working options, ongoing professional development, and a collaborative,