Senior Regulatory Affairs Manager with key responsibility within CMC

We are currently searching for an experienced CMC Regulatory Affairs Manager to strengthen the regulatory team in maintaining CMC dossier documentation in Oncoinvent’s key territories (EU and USA).

The Regulatory Affairs Department primary objective is to drive the secure product development for Oncoinvent according to required standards and deliver according to ambitious milestone plans for the products under clinical development.

The department should be able to proactively engage with internal and external stakeholders and be a key resource for advising on clinical and product development strategy for the company. Experience in working with CRO’s is important.

This position is an exciting opportunity to work in an innovative and dynamic bio-technology start-up company and participate in the development of novel pharmaceuticals. The company has its lead product candidate Radspherin® in first-in-human/phase I studies. Radspherin® is a radiopharmaceutical designed to treat peritoneal carcinomatosis originating from ovarian cancer and colorectal cancer as the first indications.

The candidates should be looking for the energy and enthusiasm in a start-up company with the ambition to make a difference for patients worldwide.

Key responsibilities:

The main purpose of the CMC Regulatory Affairs Manager position will be the following areas:

• Responsibility for compiling, reviewing, updating and maintaining the drug substance and drug product dossier documentation for regulatory submissions.
• Supporting change procedures for the manufacturing process.
• Maintaining company’s up-to-date knowledge of regulatory requirements and secure implementation across teams.
• Cooperation with regulatory consultants
• Support of regulatory submissions for clinical trials and marketing authorization applications

Qualifications and experience:

The holder of this position should have the following documented qualifications and experience:

• Life Science/Pharmacy degree in relevant discipline. An advanced degree (MSc/PhD).
• Minimum of 5-7 years of CMC specialized regulatory experience.
• Experience with international applications for clinical trials and marketing authorizations.
• Practical experience from any area within Chemistry, Manufacturing and Control would be advantageous.
• Experience with cancer drugs and/or experience with radiopharmaceuticals would be advantageous.
• Strong writing and communication skills. Fluency in English, both oral and written.
• A successful candidate has a demonstrated ability to deliver on challenging goals and have relevant scientific competence. The ability to work well with others, have a systematic - and an analytical approach will be appreciated.

Location

• The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo and reports to the Head of the Regulatory Department.

Application deadline:  We are reviewing the applications on a rolling basis.

Please submit your application with a motivational letter stating “why Oncoinvent” and what you can contribute to the position as well as an updated CV. Applications without this will not be reviewed further.