Opis:
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.
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 welness benefits
- Office in Warsaw - Mokotów
Your tasks
- 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.
What we expect
Required:
- 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.
Preferred:
- 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.
Employment agency entry number 47
this job offer is intended for people over 18 years of age
12 mar 2025;
from:
www.jobs.pl