Global Regulatory Manager: Strategy & Submissions Lead

Pfm; 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

Home working allowance

Vacation

Job summary

Precision for Medicine is recruiting a Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, agency meetings, and regulatory submissions. The role coordinates and prepares documents for submissions to regulatory authorities and ethics committees, and may lead regional or global projects.

The ideal candidate has senior regulatory experience, CRO/pharma background, and strong knowledge of EU/US processes.

Qualifications

• Bachelor's degree or equivalent in a scientific/healthcare discipline.
• 5+ years regulatory experience for Manager level and 7+ years for Senior Manager.
• Regulatory affairs experience in CRO or pharmaceutical industry with leadership of clinical submissions.
• Knowledge of EU/US regulatory processes and guidelines.
• Willingness to travel domestically and internationally.

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle.
• Coordinate and review submissions to Regulatory Authorities and Ethics Committees (CTA/IND, annual reports, amendments, orphan designations, paediatric planning, etc.).
• Develop and/or review documents for regulatory submissions to Authorities and Ethics Committees.
• Represent Global Regulatory Affairs at project team meetings with internal and external stakeholders.
• Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists.
• Maintain project plans, trackers and regulatory intelligence tools; update Regulatory Leadership.
• Mentor Regulatory Affairs staff as required.
• Contribute to regulatory strategy and timelines for new study opportunities.

Skills

Regulatory leadership

Cross-functional collaboration

English communication

Travel readiness

Education

Bachelor's degree in science/healthcare

Job description

Precision for Medicine is recruiting a Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, agency meetings, and regulatory submissions. The role coordinates and prepares documents for submissions to regulatory authorities and ethics committees, and may lead regional or global projects.

The ideal candidate has senior regulatory experience, CRO/pharma background, and strong knowledge of EU/US processes.