Targovax is seeking a Head of Regulatory Affairs
14.09.2018 | AjankohtaistaTyöpaikkailmoitukset
Targovax: Activating the patient's immune system to fight cancer
Targovax is a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine. Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It is used as a therapeutic cancer vaccine and has been shown to activate the immune system to generate tumor-specific immune responses. Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS. The TG vaccine program has shown a signal of efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. Targovax has offices in both Oslo and Helsinki.
We seek dedicated, passionate and hardworking individuals who will bring their experiences, unique perspectives and problem-solving skills to our team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a difference in the lives of patients by working towards our mission: Activating the patient’s immune system to fight cancer.
Head of Regulatory Affairs
Targovax is seeking an experienced regulatory professional who can lead the Regulatory department. The Head of Regulatory Affairs will contribute to the development of regulatory strategy, serve as the regulatory lead on project teams, manage external regulatory CROs and act as the regulatory contact for local/EU/US health authorities. The position will report to the Chief Medical Officer and be part of the R&D Execute.
The major responsibilities for this position are:
- Development of regulatory strategy, ensuring that product manufacturing, pre-clinical and clinical development plans are sound and comply with EU and US regulatory requirements
- Overseeing the planning, preparation and collaboration with CROs or other partner organizations when submitting new regulatory submissions to competent authorities and GMO authorities and maintain these
- Acting as internal resource for regulatory input on pre-clinical, clinical and product development
- Plan, coordinate and execute interactions and meetings with regulatory agencies
- Monitor and evaluate impact of relevant international regulatory regulations
- Support due diligence
- Contribute to maintenance of SOPs and develop internal regulatory systems
- Manage, at present, one Regulatory Coordinator
All responsibilities and accountabilities listed for this position requires execution in accordance with current EU and US GxP requirements.
The position will require close cross-functional collaboration within Targovax.
- Science or relevant healthcare professional degree
- 5+ years of experience of regulatory affairs with local and European/EMA interactions preferably also with the FDA including INDs and product license applications
- Oncology experience, preferable
- GMO and biotech experience, preferable
- Detailed knowledge of regulatory processes and regulations
- Experience with regulatory strategy formulation
- Outstanding written and oral communication skills in English
- Organization and multi-tasking skills
- Knowledge from working with EU and US GXP requirements in different stages of development
- Ability to work independently and at the same time be a good team player
- People management experience, preferable
Travelling abroad will be required from time to time.
The position will be located in Targovax’s office in Oslo, Norway. Residency in other countries will also be considered.
If you have any questions to the position, please contact:
Renate Birkeli, HR:
Phone: +47 922 61 624
How to apply:
Please send in English your CV together with a one-page motivational letter on why you are suited for the position by 8 October 2018 to:
Phone: +47 922 61 624
To learn more about us, please visit: www.targovax.com