Regional Regulatory Affairs Director – International

GSK

Lead regional regulatory strategy for GSK's biopharmaceutical assets while ensuring compliance and fast approvals. Collaborate with global teams to develop regulatory strategies across international markets.

Posted 5/10/2026full-timePoznan • 🇵🇱 PolandLead💰 PLN 410,250 - PLN 683,750 per yearWebsite

About the role

Key responsibilities & impact

Lead the development of appropriate business-focused, high-quality, timely regional regulatory strategy and its execution for assigned asset(s)
Responsible for the development of optimal regional regulatory strategy and for its delivery according to plan
Provide deep regulatory knowledge and international markets expertise
Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective
Proactively develop and implement regional regulatory strategy aligned with enterprise goals and local opportunities
Represent Regulatory function in collaboration with regional stakeholders
Drive early engagement with LOC RAs proactively sharing knowledge on clinical development programs and key project milestones

Requirements

What you’ll need

Bachelor Degree in a scientific discipline such as life sciences, pharmacy, medicine, or equivalent
Proven experience of leading regional development, submission and approval activities in region(s) and/or globally
Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
Extensive experience of all phases of the drug development process in regulatory affairs
Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally
Extensive knowledge of relevant areas of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area

Benefits

Comp & perks

Private healthcare
Additional paid days off
Life insurance
Private pension plan
Fully paid parental leave & care of family member leave

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategy developmentregulatory intelligenceclinical trial requirementslicensing requirementsdrug development processsubmission and approval activitiesmilestone meeting organizationtherapeutic knowledge development

Soft Skills

leadershipcollaborationrelationship managementorganizational skillscommunication

Certifications

Bachelor Degree in life sciencesBachelor Degree in pharmacyBachelor Degree in medicine