Senior Cross-Regional Regulatory Affairs Analyst

Johnson & Johnson Innovative Medicine; Warszawa; On-site; PLN 186,000 - 299,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Warsaw, Poland, seeks a Senior Analyst Cross Regional Regulatory Affairs for a one-year fixed-term contract.

This role supports regional regulatory strategies, collaborates with Global and Regional leaders, and leads regional teams to implement regulatory plans.

The position requires extensive global regulatory experience, strong English communication, and the ability to coordinate across time zones in a matrix environment.

Qualifications

• Breadth of global regulatory affairs experience in global drug development and commercialized products.
• Pharma Regulatory experience in at least one major geographic region preferred, with prior global regulatory exposure/experience.
• Demonstrated ability to independently handle multiple projects, excellent verbal and written communication skills, ability to work in a multi-cultural environment and in a matrix environment.
• Must be able to work flexible hours to accommodate meetings across different time zones.
• Excellent English verbal and written communication skills.
• Experience in leading project teams; demonstrated project management skills.
• Experience in Asia Pacific, Latin America and EMEA countries is desirable.
• Good working knowledge of regulations and guidelines related to drug development and registration; knowledge management skills desirable.

Responsibilities

• Implement the regional regulatory strategy, including the regulatory submission plans, in line with R&D and regional objectives.
• Represent regions and contribute to regional and global regulatory strategy in product-related teams.
• Advise product teams on regional and local requirements and impact of supply chain decisions.
• Lead Regional Working groups to ensure timely execution of product objectives.
• Facilitate tactical implementation at the regional level and maintain communications with regional/global teams.
• Provide regulatory input for inspections, audits, and product complaints.
• Liaise with Local operating companies for meetings with regulatory agencies.
• Oversee development of labeling strategies for regional markets.
• Prepare documentation for registration dossiers (iCTD/ACTD) and reuse strategies.

Skills

Global regulatory affairs

Regulatory submission planning

Project management

English communication

Matrix leadership

Time-zone coordination

Education

B.A./B.S. in science

Job description

Johnson & Johnson Innovative Medicine in Warsaw, Poland, seeks a Senior Analyst Cross Regional Regulatory Affairs for a one-year fixed-term contract.

This role supports regional regulatory strategies, collaborates with Global and Regional leaders, and leads regional teams to implement regulatory plans.

The position requires extensive global regulatory experience, strong English communication, and the ability to coordinate across time zones in a matrix environment.