Remote Regulatory Manager - Clinical Submissions & Strategy

Precision for Medicine; Warszawa; Remote; 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 is hiring a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and orphan/paediatric planning. You will coordinate regulatory documents for submissions and lead regional/global regulatory activities while ensuring timely, compliant submissions.

The role requires CRO/pharma regulatory experience, and the ability to travel domestically and internationally.

Qualifications

• Bachelors degree or equivalent in science/healthcare.
• 5 years regulatory experience for Manager level; 7+ years for Senior Manager.
• Regulatory affairs experience in CRO or pharmaceutical industry.
• Experience leading clinical submissions and regulatory strategies.
• Willingness to travel domestically and internationally.

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle.
• Coordinate and review CTA/IND submissions and amendments.
• Develop documents for submission to Regulatory Authorities/Ethics Committees.
• Represent Global Regulatory Affairs in project teams with internal/external stakeholders.
• Lead or participate in regional/global regulatory projects and submissions.
• Oversee Regulatory Affairs Specialists to meet submission targets.
• Maintain project plans, trackers and regulatory intelligence tools.
• Support regulatory strategy for new study opportunities and timelines.
• Contribute to corporate quality initiatives and keep up with regulations.

Skills

Regulatory affairs

Clinical submissions

CTA/IND

Regulatory strategy

Orphan designations

Paediatric planning

Global regulatory

Team leadership

Regulatory meetings

Travel readiness

Education

Bachelor's degree or equivalent

Job description

Precision for Medicine is hiring a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and orphan/paediatric planning. You will coordinate regulatory documents for submissions and lead regional/global regulatory activities while ensuring timely, compliant submissions.

The role requires CRO/pharma regulatory experience, and the ability to travel domestically and internationally.