Senior Regulatory Affairs Professional, Randstad

Senior Regulatory Affairs Professional

Randstad

Location:

Poland, Warszawa

Category:

-

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

We are looking for an experienced Senior Regulatory Affairs Professional to support the implementation of regional regulatory strategies for pharmaceutical products at various stages of their lifecycle. This role involves close collaboration with global and regional teams to effectively execute regulatory submission plans, support product approvals, and ensure compliance with local and regional regulatory requirements.

Job Responsibility:

Implement regional regulatory strategies in alignment with R&D and global regulatory objectives
Collaborate with global and regional teams (e.g., Global Regulatory Teams, Submission Teams, Labeling Working Groups, CTA Working Groups, and clinical teams)
Provide regulatory guidance on regional and local requirements, including the impact of supply chain decisions on registrations
Lead Regional Working Groups to ensure timely execution of regulatory objectives and alignment with global teams
Support and communicate regional regulatory activities, ensuring effective coordination between global and local regulatory teams
Monitor regulatory developments and assess their impact on product strategies
Prepare and review registration dossiers (e.g., International Common Technical Document (iCTD), ASEAN Common Technical Document (ACTD)) and manage country-specific submission requirements
Oversee responses to Health Authority inquiries and support local teams in regulatory agency interactions
Develop and manage labeling negotiation strategies and documentation for regulatory approvals
Contribute to compliance activities, including audits, inspections, and post-approval commitments

Requirements:

Bachelor's degree in Life Sciences, Pharmacy, or a related field
Minimum of 6 years of industry experience, including at least 3 years in Regulatory Affairs
Broad experience in global drug development and commercialized products
Regulatory experience in at least one major geographic region (global exposure preferred)
Strong ability to manage multiple projects independently in a matrix environment
Excellent verbal and written communication skills in English
Ability to work flexible hours to accommodate meetings across different time zones
Experience in leading cross-functional teams and demonstrated project management skills

Nice to have:

Experience in Asia-Pacific (APAC), Latin America (LATAM), or non-EU markets
Strong understanding of global regulatory guidelines and procedures
Experience in contributing to drug development strategies and lifecycle management
Knowledge of regulatory intelligence and impact assessment of evolving regulations

What we offer:

Opportunity to work in a global environment and contribute to international regulatory projects
Professional development in regulatory strategy and implementation
Flexible working hours and hybrid work option
Collaboration with cross-functional teams and access to cutting-edge regulatory trends
Medical and wellness benefits

Additional Information:

Job Posted:

March 31, 2025

Expiration:

April 10, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

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