Senior Regulatory Affairs Specialist

Company: Pauwels Consulting Agency

Location: Puurs-Sint-Amands, Belgium
Seniority: Senior
Employment type: Full-time
Posted: 14 days ago
Offer language: English

Regulatory Affairs

Job description

Our client, a prominent pharmaceutical organization, is seeking an experienced professional to lead regulatory activities within the Benelux region. The role focuses on ensuring the quality and compliance of regulatory data and processes while managing marketing authorizations for medicinal products.

Responsibilities

Manage the preparation, submission, and follow-up of registration dossiers, renewals, and variation dossiers for medicinal products.
Lead the initiation, review, and implementation of label and artwork changes to ensure full compliance with regional regulations.
Provide strategic regulatory expertise to internal stakeholders and participate in launch planning and business unit meetings.
Support complex projects including marketing authorization transfers and legal entity changes across the regional market.
Draft and review local and global SOPs, work instructions, and other quality-related documentation.
Oversee the handling of CPP and ancillary document requests for emerging markets and maintain internal regulatory databases.
Coordinate with production plants and hubs to manage out-of-stock notifications and artwork approvals.

Requirements

You have a Bachelor’s degree in a scientific or related discipline.
You bring 8+ years of experience in regulatory affairs, conformance, or compliance within the pharmaceutical industry.
You possess advanced knowledge of EU and global regulatory procedures, marketing authorizations, and drug development practices.
You have experience working in a GMP environment and utilizing regulated document management tools.
You’re an organized and analytical professional with strong skills in technical writing and stakeholder influencing.
You have a perfect command of Dutch with good knowledge of English.

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