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Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Do you want to work with regulatory affairs and have experience from regulatory work in a product development perspective? Are you interested in joining a small growing company with an innovative and creative company culture and interesting opportunities? If so, you should keep reading since we are now looking for a Regulatory Affairs Manager to Cinclus Pharma Holding AB.

As Regulatory Affairs Manager at Cinclus Pharma, you will be part of a professional drug product development team at the Head Quarters in Stockholm.

Responsibilities
You will work with regulatory activities in Cinclus Pharma projects in close collaboration with clinical operations, medical, nonclinical, CMC and other relevant functions. Day to day activities may include:

·      Providing regulatory expertise to clinical trial study teams and liaise with contract research organizations (CROs) to ensure that clinical trials are conducted in compliance with the latest regulations and guidelines

·      Working in the CTIS (Clinical Trial Information System)

·      Contributing to the planning, preparation and delivery of regulatory submissions such as INDs/CTAs/authority interactions with focus on US and EU

·      Collaboration with publishing teams to assure efficient delivery to project timelines

·      Managing, tracking and archiving regulatory submissions

·      Monitoring regulatory intelligence


Requirements

* University degree within the pharmaceutical area or similar

* At least two to three years of experience in regulatory affairs

* Have an understanding of regulatory requirements and guidelines

* Professional level of English

You are used to, and enjoy, communication and collaboration both internally and externally with colleagues, authorities, and affiliates. You have an engaged, flexible and focused way of working, with a motivation to learn and develop.

Contact and application
If you are interested, please apply to the role at
hr@cincluspharma.com no later than July 30 2024. If you have questions, please contact Malin Filler, Head of Regulatory Affairs, malin.filler@cincluspharma.com