Head of Regulatory Affairs and QA – To Ultimovacs
Regulatory Affairs · Europe
On behalf of Ultimovacs we are now looking for an experienced Head of Regulatory Affairs and Quality Assurance. This is a unique mix of strategic thinking as well as hands on implementation in a company with global aspirations. Ultimovacs is a pharmaceutical company developing novel immunotherapies against cancer. The lead product candidate is UV1, a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. The company is listed on the Oslo Stock Exchange. For this position you can be based anywhere in Europe but need to be in the company’s HQ in Oslo from time to time.
- Provide regulatory guidance to CMC, preclinical/nonclinical and clinical development of pipeline and development products.
- Manage interaction with Ultimovacs regulatory agent in the US and maintain INDs.
- Develop regulatory plan to market for pipeline and development products.
- Prepare for and lead meetings with regulatory authorities.
- Support the clinical operations function in preparation of protocols, clinical study reports, clinical trial applications and regulatory issues relating to clinical studies.
- Prepare and maintain Investigator’s Brochures.
- Hold the overall responsibility for dossier drafting, reviewing, approving and managing submission of documentation to regulatory agencies (Module 1-5).
- Maintain current knowledge of relevant regulations and guidelines.
- Coordinate work with external regulatory consultants.
- Provide strategic regulatory input and guidance to meet company objectives
- Lead and develop QA activities via one direct report
- Preferred 10+ years of experience in regulatory affairs for development of pharmaceuticals.
- Experience with therapeutic vaccines is a plus.
- Relevant experience in regulatory submissions.
- Experience in preparing regulatory development plans.
- Experience preparing for and leading regulatory agency meetings.
- Working knowledge of EMA, FDA and ICH regulations/guidance and requirements.
- Knowledge across various functional disciplines to include GMP and GDP experience, Quality Systems Management, GCP and GLP is a plus.
- Good judgement, problem-solving skills, strong analytical and organization skills; attention to detail required.
- A pragmatic, solution-oriented approach, with high drive and a high degree of independence.
- Comfortable working in relatively small teams.
- Fluent oral and written English language
Welcome with your application www.haegercarlsson.com
Questions are answered by Rolf Carlsson, +46(0)70-316 12 68, email@example.com