Global Regulatory Submissions Lead - 12M Contract

Freyr Solutions; Polska; Hybrid; PLN 349,000 - 481,000; Full time

Job summary

Freyr Solutions is seeking an experienced Regulatory Submission Manager to lead global regulatory submissions across multiple products. You will coordinate timelines, manage content development, and guide cross-functional teams to ensure compliant and timely filings.

You will also help evolve submission standards, templates, and intelligence frameworks, while mentoring junior colleagues and aligning with RA Liaisons and GRAD affiliates.

Qualifications

• Recognized SME in regulatory submission types and technical guidance.
• Experience coordinating cross-functional stakeholders and managing submission content plans in Veeva (preferred).
• Ability to advise on health authority requirements and RSM processes.

Responsibilities

• Plan and oversee global/regional submission content and resource plans.
• Lead regulatory submission teams and coordinate timelines and action items.
• Coach and train junior colleagues in submission management.

Skills

Regulatory submissions

Project management

Stakeholder coordination

Leadership

Regulatory intelligence

Education

BA/BS life sciences or related

MA/MS/MBA

PharmD/PhD

Tools

Veeva

Smartsheet

SharePoint

Microsoft Office

Job description

Freyr Solutions is seeking an experienced Regulatory Submission Manager to lead global regulatory submissions across multiple products. You will coordinate timelines, manage content development, and guide cross-functional teams to ensure compliant and timely filings.

You will also help evolve submission standards, templates, and intelligence frameworks, while mentoring junior colleagues and aligning with RA Liaisons and GRAD affiliates.