Regulatory Affairs Manager

Role Overview

As a Regulatory Affairs Manager, you will ensure that the company’s pharmaceutical products comply with all applicable European and German regulations. You will be responsible for preparing and submitting regulatory dossiers, maintaining product licenses, and supporting internal teams with regulatory guidance throughout the product lifecycle. This role requires a proactive professional who can navigate complex regulatory landscapes, manage multiple projects simultaneously, and interface with both national and European health authorities.

Key Responsibilities

• Regulatory Strategy & Compliance
• Develop and execute regulatory strategies to support new product approvals, variations, line extensions, and renewals.
• Ensure compliance with EU pharmaceutical regulations
• Monitor, interpret, and communicate regulatory changes and industry updates to internal stakeholders.
• Submissions & Dossier Management
• Prepare, compile, and submit regulatory dossiers, including Marketing Authorization Applications (MAAs), variations, and renewals.
• Maintain up-to-date regulatory documentation, labeling, and product files.
• Liaise with the European Medicines Agency (EMA) and German authorities regarding submissions, queries, and approvals.
• Cross-Functional Collaboration
• Work closely with R&D, Quality Assurance, Clinical Development, and Marketing teams to ensure regulatory considerations are embedded in product development and commercialisation.
• Provide regulatory guidance on clinical study protocols, labeling, packaging, and promotional materials.
• Audits & Inspections
• Support or lead regulatory inspections, audits, and compliance checks.
• Coordinate responses to audit findings and health authority queries.
• Monitor post-approval requirements and ensure timely submissions of variations, renewals, and safety updates.
• Advise internal teams on regulatory implications of product changes.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related field.
• ~5 years of regulatory affairs experience in the pharmaceutical industry.
• Strong knowledge of EU and German pharmaceutical regulations, EMA guidelines, and competent authority procedures.
• Proven experience managing MAAs, variations, renewals, and regulatory submissions.
• Excellent German and English communication skills (written and verbal).
• Detail-oriented, highly organized, and able to manage multiple projects simultaneously.
• Experience working in a hybrid and international environment is advantageous.

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