For our Client, one of the biggest Pharmaceutical Companies worldwide we are looking for a Senior RA Professional EMEA, who will be responsible for supporting the Regulatory Liaison (RL) for a broad range of regulatory activities in the Established Products area in the Europe/Middle East/Africa (EMEA) region, providing regulatory input on submission documents to ensure compliance with regulatory requirements. You may also provide regulatory support for and appropriate follow-up to inspections, audits and issue management, acting as the regulatory representative on specific multi-disciplinary teams as well as provide support in portfolio optimization activities.
If you have relevant experience and would like to participate in the process, apply for this role.
what we offer- annual performance-based bonus
- opportunity to work with a leader in the pharmaceutical industry
- a tangible impact on regulatory processes and the development of innovative products
- hybrid work model (office in Warsaw)
- additional leave benefits (e.g., bereavement leave)
- comprehensive medical care and life insurance
- employer-sponsored retirement plan
- lifecycle & Portfolio Management – Support post-approval regulatory activities, optimize portfolio strategies, and address regulatory challenges across regions
- regulatory Strategy & Compliance – Provide strategic input on regulatory issues, monitor industry trends, and ensure compliance with evolving regulations
- regulatory Agency Liaison – Act as a key contact for Health Authorities, coordinate regulatory meetings, address inquiries, and negotiate product labeling
- documentation & Submissions – Oversee the preparation, review, and submission of regulatory documents (IND, NDA, CTA, CTD) and ensure timely regulatory filings
- clinical Trial Applications & Post-Approval Commitments – Ensure compliance of clinical trial plans with regulatory standards and manage post-approval commitments
- cross-Functional Collaboration – Work closely with global and regional teams, local regulatory offices, and industry stakeholders to drive regulatory success
- regulatory Process Optimization – Improve regulatory workflows, track submission timelines, and contribute to the development of standard operating procedures
- regulatory experience in drug development and commercialization. As this function is responsible for a broad portfolio of established products additional experience with late life cycle management & issue management will be an advantage,
- · experience with EU regulatory procedures (CP, DCP/MRP, referrals & national)
- university degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience,
- · experience in working in project teams and/or a matrix organization
- the ability to work successfully within a collaborative team environment and as an individual contributor and decision maker within a cross-functional organization
Employment agency entry number 47
this job offer is intended for people over 18 years of age
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