Senior Regulatory Affairs Analyst – Global & Regional

Biopharma Asia; Warszawa; Hybrid; PLN 191,000 - 308,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave (min 12 weeks)

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Warsaw, Poland, seeks a Senior Analyst, Cross Regional Regulatory Affairs, for a one-year fixed-term contract. You will support regional regulatory strategy, collaborate with Global and Regional Leaders, and lead regional working groups to align with product objectives.

Applicants should have a BA/BS in science, 6 years of regulatory experience, and excellent English communication. Experience across Asia Pacific, Latin America, and EMEA is desirable, with ability to work in

Qualifications

• BA/BS in science or health-related discipline is required.
• 6 years relevant regulatory experience (3 years pharm regulatory).
• Breadth of global regulatory affairs experience in global drug development and commercialized products.
• Excellent English verbal and written communication skills.

Responsibilities

• Implement regional regulatory strategy and submission plans aligned with R&D, regional and local objectives.
• Represent regional interests in Global/Regional regulatory teams and lead where appropriate.
• Advise product teams on regional/local requirements and impact of supply chain decisions.
• Lead Regional Working Groups to ensure timely execution of product objectives and alignment with global teams.
• Coordinate regulatory input for inspections, audits, and product complaints.

Skills

Regulatory affairs

English communication

Project management

Matrix environment

Multi-cultural teamwork

Flexibility for meetings across time-z

Education

B.A./B.S. in science/relevant health-related discipline

Job description

Johnson & Johnson in Warsaw, Poland, seeks a Senior Analyst, Cross Regional Regulatory Affairs, for a one-year fixed-term contract. You will support regional regulatory strategy, collaborate with Global and Regional Leaders, and lead regional working groups to align with product objectives.

Applicants should have a BA/BS in science, 6 years of regulatory experience, and excellent English communication. Experience across Asia Pacific, Latin America, and EMEA is desirable, with ability to work in