Senior Global Regulatory Manager – Remote

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

Benefits offered by this job

Private medical insurance

MultiSport Card

Life insurance

Pension

Home working allowance

Vacation

Job summary

Precision for Medicine is seeking a Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, agency meetings, and orphan designations. You will coordinate regulatory documents for submissions to Regulatory Authorities and Ethics Committees.

The role requires leading regional/global submissions, overseeing Regulatory Affairs Specialists, maintaining regulatory intelligence, and ensuring compliance with ICH-GCP.

Qualifications

• Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
• 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level.
• Regulatory affairs experience working for a CRO or within the Pharmaceutical Industry, and experience leading Clinical Submissions.
• Availability for domestic and international travel including overnight stays.
• Proficient in English communication, both verbal and written.

Responsibilities

• Provides regulatory guidance throughout the clinical development life cycle.
• Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, and regulatory meetings.
• Develops and/or reviews documents for submission to Regulatory Authorities and/or Ethics Committees.
• Serve as representative of Global Regulatory Affairs at project team meetings with external and internal customers.
• Lead project teams regionally or globally and oversee Regulatory Affairs Specialists.
• Maintain project plans and regulatory trackers; keep Regulatory Leadership updated.

Skills

Regulatory strategy

Regulatory submissions

Project leadership

Regulatory affairs experience

International regulatory

English communication

Education

Bachelor's degree in life sciences

Job description

Precision for Medicine is seeking a Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, agency meetings, and orphan designations. You will coordinate regulatory documents for submissions to Regulatory Authorities and Ethics Committees.

The role requires leading regional/global submissions, overseeing Regulatory Affairs Specialists, maintaining regulatory intelligence, and ensuring compliance with ICH-GCP.