KLIFO GmbH

Regulatory Affairs Officer (m/f/d)

München
Feste Anstellung
Vollzeit

Schnelle Bewerbung

KLIFO GmbH is currently expanding its service offering in Germany by introducing an end-to-end drug
development consultancy including a Regulatory Affairs Solutions department, similar to what the company has in Denmark.

The Regulatory Affairs Officer is responsible for collaboration with clients as well as competent
authorities and the execution of projects according to the clients´s expectations.

The position requires a hands-on approach to servicing existing and new clients in the DACH region.

You will report to our Director, Regulatory Affairs DACH in Munich.

The position as Regulatory Affairs Officer mayinvolve:

Project management
Liaison with competent authorities
General regulatory affairs work
Management of regulatory procedures
Preparation and submission of CTA as well as other regulatory documents, e.g. (non-exhaustive list): 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
Cross-functional collaboration within KLIFO
Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Qualifications:

M.Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in the area of clinical research in the pharmaceutical industry/CRO
Excellent knowledge of regulatory requirements and ICH-GCP
Excellent communication skills (written and verbal)
Fluent in German and English
Experienced user of Microsoft Office Package and good understanding of databases
Strong organizational skills with attention to details
Willingness to work from client sites, when required

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player, possesses excellent planning skills and is fluent, spoken and written, in German and English.

We offer:

Work within different therapeutic areas and with tasks of varying complexity
Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
Join a team of experienced colleagues where you use and elaborate your skills and competences
Work in an interactive, flexible and positive working environment with a high level of transparency
Opportunity to join an European-based organisation with global reach and a strong and dedicated plan for growth

Contact:

Applications including salary expectations should be sent to:
job@klifo.com marked Regulatory Affairs Officer, Munich.

Location:
KLIFO has offices in Denmark, Germany, the Netherlands and Sweden. This position is located at our office at Heimeranstrasse
35 in Munich.

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).

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. For more information, visit KLIFO.com