Global Regulatory Lead for Clinical Submissions

Precision for Medicine; Polska; On-site; PLN 190,000 - 285,000; Full time

Benefits offered by this job

Discretionary bonus

Private medical insurance

MultiSport Card

Life insurance

Pension

Job summary

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to deliver regulatory strategy and development guidance for clinical trials, orphan designations, paediatric planning, and accelerated procedures in a global setting.

The role coordinates regulatory documents for submissions to Regulatory Authorities and Ethics Committees, while guiding project teams and overseeing regulatory affairs specialists to achieve on-time deliverables.

Qualifications

• Bachelor's degree in a scientific or healthcare discipline or equivalent experience.
• 5+ years regulatory experience for Manager level and 7+ years for Senior Manager level.
• Experience leading regulatory submissions for CRO or pharmaceutical industry.
• Knowledge of EU and US regulatory processes and submission types.
• Ability to travel domestically and internationally.

Responsibilities

• Provide regulatory strategy throughout the clinical development lifecycle.
• Prepare and coordinate regulatory submissions to authorities and ethics committees.
• Lead and coordinate regulatory affairs activities to meet submission targets.
• Represent Global Regulatory Affairs in project teams and with external partners.
• Mentor Regulatory Affairs staff and support regulatory training across teams.
• Stay updated on regulatory guidelines and ensure compliance.

Skills

Regulatory strategy

Regulatory submissions

Regulatory affairs leadership

Global/regional regulatory

Cross-functional collaboration

Education

Bachelor's degree in a scientific/healthcare field

Tools

Regulatory intelligence tools

Job description

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to deliver regulatory strategy and development guidance for clinical trials, orphan designations, paediatric planning, and accelerated procedures in a global setting.

The role coordinates regulatory documents for submissions to Regulatory Authorities and Ethics Committees, while guiding project teams and overseeing regulatory affairs specialists to achieve on-time deliverables.