Regulatory Affairs Manager (m/f/d)

Ort 64295 Darmstadt
Working time model Full-time
Contract typeEmployment agency

As Regulatory Affairs Manager (m/f/d) You will be responsible for ensuring regulatory compliance for our pharmaceutical and medical products throughout their entire product lifecycle. You will ensure that regulatory requirements are identified at an early stage, implemented and integrated into the company’s and quality processes on a long-term basis. In doing so, you make a significant contribution to product compliance, patient safety and the long-term marketability of the product portfolio.

Working closely with Quality Management, Medical Affairs, Production, Research & Development, Clinical Affairs and Supply Chain, you will provide support on regulatory matters and play a key role in ensuring the regulatory compliance and market authorisation of our products.

What you can expect

  • A position of responsibility at the interface between Regulatory Affairs, Quality and Business
  • Options for shaping the further development of regulatory and quality-related processes
  • Collaboration with interdisciplinary and international teams
  • A challenging and varied role involving a high level of professional responsibility
  • Opportunities for professional and personal development
  • A modern working environment with short decision-making processes and scope for personal initiative

Your duties

Regulatory Affairs & Compliance

  • Responsibility for regulatory issues and requirements in both national and international contexts
  • Monitoring and assessing relevant regulatory changes and their impact on products and processes
  • Ensuring compliance with regulatory requirements throughout the entire product life cycle
  • Development and implementation of regulatory strategies for existing and new products
  • Preparation, maintenance and review of regulatory documentation
  • Support with authorisation, variation and registration procedures
  • Coordination and assessment of regulatory changes, variations and change control processes
  • Support with communication with public authorities and regulatory enquiries
  • Preparation for and support during regulatory inspections and audits

Quality management

  • Close collaboration with Quality Management in the implementation of regulatory and quality-related requirements
  • Assessment of regulatory impacts in the context of deviations, CAPA, change controls and risk management
  • Support with the drafting, review and updating of SOPs and quality-related documents
  • Ensuring regulatory compliance of processes, products and documentation
  • Contributing to the continuous improvement of the quality management system

Cross-functional collaboration

  • Advising internal departments on regulatory requirements
  • Liaison role between Regulatory Affairs, Quality, R&D, Production, Clinical Affairs and other relevant departments
  • Working as part of interdisciplinary project teams and on product development projects
  • Delivering or supporting regulatory training for internal stakeholders
  • Promoting a sustainable culture of regulatory compliance and quality within the organisation

Your profile

  • A degree in pharmacy, natural sciences, life sciences, medical technology or a comparable field
  • Several years’ professional experience in regulatory affairs, ideally in the pharmaceutical or medical devices industry
  • In-depth knowledge of the relevant regulatory requirements and quality standards
  • Experience with regulatory changes, change control, CAPA, risk management and quality management systems
  • A good understanding of the European regulatory framework
  • Experience in dealing with public authorities, notified bodies or external auditors would be an advantage
  • An analytical, structured and solution-oriented approach to work
  • Strong communication and coordination skills
  • A strong sense of responsibility and a meticulous, quality-focused approach to work
  • Excellent written and spoken German and English skills

You can reach us here with your questions!

Contact

Thilo Grünewald

Telephone 0151 1806 7001 
Email: karriere-jobs@sandyou.de

Location

S&You Akademiestr. 49 76133 Karlsruhe

About S&You
S&You is a brand of SYNERGIE Group – the fifth-largest recruitment agency in Europe. We help specialists and executives reach the next level in their careers – with a personalised, professional and expert approach, and exclusively through direct placement. Thanks to our many years of experience and international network, we are a key recruitment partner for many renowned companies. Make the most of our contacts and market knowledge!

Apply now