Regulatory Affairs Manager (m/f/x)

Driving SciPro’s strategic client development and commercial strategy across the DACH region for permanent and contract staffing projects

Regulatory Affairs Manager (m/f/x) | Munich area | Pharma

In this position, you will be responsible for the preparation, submission & maintenance of regulatory documentation. You will take over Regulatory Compliance, working closely with regulatory authorities and assure correct documentation and labeling.

What will your tasks as “Regulatory Affairs Manager (m/f/x)” be?

Preparation, Submission & Maintenance of Regulatory Documentation

• Compilation, submission, and management of national and European marketing authorization applications (e-CTD) via CESP, PharmnetBund, XEVMPD, PLM, Syncplicity
• Ongoing maintenance and updates of regulatory documentation (Module 1) to reflect scientific advancements (variations, renewals)
• Submission of Periodic Safety Update Reports (PSUR) to EMA

Regulatory Coordination & Compliance

• Coordination and timely response to deficiency letters from BfArM and EMA
• Review and assessment of regulatory documents for compliance with authority requirements
• Coordination and planning of new tasks such as user requirements, validation, and data migration in docuBridge and drugTrack
• Implementation of new technical and regulatory requirements

Documentation & Labeling

• Preparation and finalization of German SmPCs and package leaflets based on EU templates (MRP/DCP)
• Management and electronic archiving of internal and regulatory databases, including verification of marketing authorizations

Cross-functional Collaboration & Support

• Liaison with internal departments such as Launch Management, Portfolio Management, Artwork, Pharmacovigilance, Quality Management, and manufacturing sites
• Collaboration with corporate regulatory teams and relevant specialist departments
• Internal consulting for other departments, e.g., Marketing
• Training and onboarding support for colleagues

Process Optimization & Documentation

• Development of SOPs, work instructions, and checklists to ensure regulatory compliance

Your requirements as a “Regulatory Affairs Manager (m/f/x)”?

• Completed degree in a scientific or technical field
• Professional experience in pharmaceutical regulatory affairs within the EU (Germany national, MRP/DCP), including the preparation of eCTD sequences and submissions via CESP and PharmNet.Bund
• Hands-on experience with xEVMPD and IDMP, as well as in-depth knowledge of relevant guidelines, such as the EU IDMP Implementation Guide
• Ideally, experience in the implementation and operation of RIM systems, as well as in developing and executing data migration strategies
• Strong IT affinity and interest in digital transformation and process automation
• Excellent German and English skills, both written and spoken

Information about our client:

The company is part of an internationally active pharmaceutical company with more than 24,000 employees worldwide. They have over 35 years of experience in the research, development, and manufacturing of pharmaceutical active ingredients and generic medicines, which it distributes in more than 155 countries.

The core portfolio includes CNS products, antibiotics, HIV medications, treatments for cardiovascular diseases, digestive system disorders, diabetes, and antiallergic drugs.

Are you interested in this position? Then you should apply now!

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