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Oncoinvent presents a unique opportunity to join an expanding pharmaceutical start-up with both R&D and production established in-house which enables both hands-on lab work as well as working with external partners.

The company has solid owners and is in a clinical phase with its lead product (Radspherin®) which is produced in Nydalen.

The candidates should be looking for the energy in a start up with the ambition to make a difference. Successful candidates should be flexible, team-oriented yet able to work independently, and be analytical and results oriented.

If you would like to send us an open application, please send your application and résumé to info@oncoinvent.com

Vacancies:

Head of Regulatory Affairs

Oncoinvent AS is looking for a new Head of Regulatory Affairs to lead the regulatory department at Oncoinvent. The position is responsible for optaining and maintaining authorizations for clinical trials and marketing of medicinal products developed by Oncoinvent in EU/EEA, USA and other markets

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Oncoinvent AS Gullhaugveien 7 0484 Oslo Norway

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Head of Regulatory Affairs

Oncoinvent AS is looking for a new Head of Regulatory Affairs to lead the regulatory department at Oncoinvent.

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.
The candidate is a member of the Oncoinvent leadership team and reports to the CEO

Key responsibilities:

The main purpose of the Head of Regulatory Affairs position is to obtain and maintain authorizations for clinical trials and marketing of medicinal products developed by Oncoinvent in EU/EEA, USA and other markets targeted by Oncoinvent AS. This includes the following responsibilities:

Responsible for providing regulatory input to medicinal product development programs, such as requirements and guidelines for chemical-pharmaceutical, non-clinical and clinical development, and manufacturing.
Responsible to inform management about current and new, coming regulatory requirements applicable for medicinal products in development, manufactured and/or marketed by Oncoinvent.
Responsible for developing regulatory strategies and plans, including choice of administrative submission procedures and use of regulatory and scientific advice meetings with regulatory authorities.
Responsible for the compiling, collating and submission of clinical trial applications, scientific advice information packages and marketing authorization applications in cooperation with Oncoinvent personnel and external regulatory service providers.
Responsible for the contact with regulatory authorities for medicinal products, including response to questions and changes to application dossiers.
Responsible for the coordination of regulatory work with contract regulatory and clinical service companies and with license partners, as applicable.
Responsible for the maintenance of marketing authorizations for medicinal products, including preparation and submission of variations and changes.

Qualifications and experience:

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

As a minimum M.Sc. or equivalent education is a requirement.
Experience as a Head of Regulatory affairs; preferably in a similar type of company and/or development stage products.
Experience with cancer drugs and/or experience with radiopharmaceuticals would be advantageous.
Be fluent in English and preferably working knowledge in Norwegian.
A successful candidate has a demonstrated ability to deliver on challenging goals and have deep 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.

About Oncoinvent
Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients.

The Oncoinvent team consists of 32 employees and the company is growing.
Oncoinvent has built a Class B production and lab facility for radiopharmaceuticals. The facility received a GMP certificate from the Norwegian Medical Agency in February of 2019. The approval provides the company with the necessary flexibility and capacity for manufacturing clinical trial material., as well as developing the company further.

The company’s lead product candidate Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of metastatic cancer.

Contact:

Please submit your written application describing why Oncoinvent and what you can contribute. Any questions – please feel free to reach out to Bjørn Fuglaas at Gevirgroup AS (+47 90775752) for a confidential discussion.