Senior Regulatory Compliance Specialist

Regulatory Affairs Expert Job Description

We are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our organization, you will be responsible for ensuring the regulatory compliance of our products in the European Union and international markets.

The ideal candidate will have a strong understanding of EU and international regulations, as well as excellent communication and analytical skills. You will work closely with our cross-functional teams to develop and implement strategies to address regulatory challenges and ensure timely submission of registration dossiers.

Key Responsibilities :

• Compilation, evaluation, and submission of complete registration dossiers to specific regulatory agencies;
• Support in developing and writing clear arguments and explanations for deficiency letters;
• Maintenance of approved dossiers and RA internal databases;
• Compilation and evaluation of ASMF;
• Writing clear, accessible product labels and patient information leaflets;
• Review of marketing materials;
• Audit or feasibility checks of dossiers for registration in required markets and coordination of regional audits;
• Stay updated on regulatory requirements (EU, national, and international legislation), guidelines, and customer practices relevant to all export markets.

Requirements :

Your Benefits :

We offer a dynamic and challenging work environment, opportunities for growth and development, and a competitive compensation package.

What We're Looking For :

We're looking for someone who is highly disciplined, responsible, methodical, resolutive, and organized, with excellent oral and written communication and interpersonal skills. If you're a detail-oriented individual with a passion for regulatory affairs, we'd love to hear from you!