100% Remote: Teamleitung Regulatory Affairs (m/w/d) - Generika

About this job

Our client is an international pharmaceutical manufacturer headquartered in Europe. The company specializes in generics and offers a wide range of dosage forms. Our client distributes more than 600 products worldwide across various therapeutic areas. In recent years, the company has also expanded its activities to Germany. In this context, we are looking for a person with experience in collaborating with German and European authorities (e.g., BfArM and EMA).

Team Lead Regulatory Affairs (m/f/d)

100% Remote

Responsibilities

• Team Leadership & Development: Initially lead 1 Regulatory Affairs employee – the team is to be further built up and additional Regulatory Affairs Managers hired.
• Regulatory Strategy & Compliance: Development and implementation of regulatory strategies to ensure compliance with national and international regulations (e.g., EMA, BfArM, etc.).
• Regulatory Submissions: Preparation, review, and submission of regulatory documents such as product dossiers, marketing authorization applications, variations, and renewals to the competent authorities.
• Authority Collaboration: Central point of contact for national and international regulatory authorities. Responding to authority inquiries, organizing and attending meetings, and ensuring timely feedback and communication.
• Product Development Support: Regulatory advice during product development. Ensuring that new products meet all relevant regulatory requirements, including participation in design reviews and risk assessments.
• Documentation & Labeling: Review and ensure the regulatory compliance of product labeling, advertising and promotional materials, and clinical documentation.
• Post-Market Surveillance & Reporting: Monitoring post-market regulatory obligations, including reporting of adverse events, field safety measures, and product recalls.
• Regulatory Intelligence: Monitoring regulatory changes and standards. Assessing the impact on the company and communicating relevant updates to internal stakeholders.
• Interdisciplinary Collaboration: Close collaboration with Quality Assurance, Research and Development, Production, and other departments to implement regulatory requirements throughout the company.

Qualifications

• Completed degree in natural sciences or pharmacy.
• At least 5 years of professional experience in Regulatory Affairs in the pharmaceutical industry, ideally in the generics sector.
• Experience with EU drug approval procedures.
• Very good understanding of global regulatory frameworks, especially EMA, FDA, and ISO.
• Strong written and verbal communication skills.
• Analytical mindset and strong problem-solving skills.
• Structured, detail-oriented approach to work and ability to manage multiple projects simultaneously.
• Proficient use of regulatory submission tools and relevant software systems.
• Fluent German and English language skills.

Benefits

• An inclusive work environment with development opportunities.
• Attractive salary and benefits package.
• Very flexible conditions with a 100% home office option (with occasional/rare travel).
• Contribution to international and innovative projects with global reach.

Silvio Di Meglio Managing Director at TRIGA Consulting 089-809130721