Remote Regulatory Manager – Global Trials & Strategy

Precision Medicine Group; Polska; Hybrid; PLN 190,000 - 285,000; Full time

Benefits offered by this job

Discretionary annual bonus

Private medical insurance

MultiSport card

Life insurance

Pension

Home working allowance

Vacation

Job summary

Precision for Medicine in Poland is seeking a Regulatory Manager/Senior Regulatory Manager to guide regulatory strategy and oversee submissions for clinical trials, orphan designations, and accelerated procedures.

The role requires CRO/pharma regulatory affairs experience, strong English, and willingness to travel domestically and internationally. A senior level demands 7+ years of regulatory work. Join a global team delivering high-quality submissions.

Qualifications

• Bachelor's degree in a scientific or healthcare field.
• 5 years regulatory experience for Manager level; 7 years for Senior Manager level.
• Experience leading regulatory submissions (CTA/IND, amendments) and regulatory meetings.
• CRO or pharmaceutical industry regulatory affairs experience.
• Ability to travel domestically and internationally.
• Strong English communication skills.

Responsibilities

• Provide regulatory strategy and guidance across the clinical development lifecycle.
• Coordinate and prepare regulatory submissions to authorities and ethics committees.
• Lead or participate in regulatory authority meetings and scientific advice procedures.
• Oversee regulatory documentation to ensure compliance with standards.
• Work with project teams and mentor regulatory staff.
• Maintain regulatory plans, trackers, and intelligence tools.
• Stay updated on global regulations and guidelines for drug development.

Skills

Regulatory strategy

Regulatory submissions

Project leadership

Regulatory guidance

International travel

Education

Bachelor's degree in scientific/healthcare field

Tools

Regulatory intelligence tools

CTA/IND submissions systems

Job description

Precision for Medicine in Poland is seeking a Regulatory Manager/Senior Regulatory Manager to guide regulatory strategy and oversee submissions for clinical trials, orphan designations, and accelerated procedures.

The role requires CRO/pharma regulatory affairs experience, strong English, and willingness to travel domestically and internationally. A senior level demands 7+ years of regulatory work. Join a global team delivering high-quality submissions.