Regulatory Affairs Officer

Join an international drug and device development consultancy and contribute with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

KLIFO Regulatory Affairs Solutions (RAS) ensures that expert regulatory advice and insight are embedded in our clients’ drug and device development projects. In RAS, we are a team of 15 highly specialised experts working across different regulatory areas to assist our clients in navigating the regulatory landscape. Our clients come from the pharma, biotech and medtec industries, and we work from client sites when required.

In the role as Regulatory Affairs Officer, you’ll contribute by:

• Leading RAS projects from A-Z
• Liaising with clients and competent authorities
• Managing regulatory procedures
• Preparing and submitting CTA and other regulatory documents, e.g. briefing packages, IMPD, IND, MAA/NDA, variations, renewals, changes in the clinical trials, notification at the end of the clinical trials
• Writing and reviewing SOPs
• Supporting projects in other departments based on your experience and skills

Your background and qualifications

You possess a collaborative mindset and work in a structured way with an eye for detail. You enjoy working within different thera­peutic areas and with tasks of varying complexity, and you thrive in a client-focused and supportive role. You want to contribute to a culture of trust and transparency.

Furthermore, you:

• Have a M.Sc. in the life sciences field or RA specific diploma/master
• Have a minimum 2 years of experience with regulatory affairs in the area of clinical research in the pharmaceutical industry/CRO
• Possess excellent knowledge of regulatory requirements and ICH-GCP
• Have excellent communication skills (written and verbal)
• Are fluent in German and English
• Are an experienced user of Microsoft Office Package and good understanding of databases

Why join KLIFO?       

• Join an organisation where we value people and their expertise as the greatest asset
• Enter a flexible workplace with a culture based on trust, transparency and respect
• Work with some of the most experienced and dedicated colleagues in the life-science industry
• Contribute with your expertise across different therapeutic areas
• Develop tailor-made solutions based on cross-disciplinary collaboration
• Cultivate successful relationships with our clients
• Be part of an organisation that sees knowledge-sharing as the road to success

Share your application

Share your application with us at moc.ofilk@boj marked “Regulatory Affairs Officer” no later than 15 September 2022. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Anne Tingsgård, VP, Regulatory Affairs Solutions at moc.ofilk@draagsgniT.ennA for more information.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).