ABOUT ITEOS THERAPEUTICS SA
iTeos Therapeutics is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies.
Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011. In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO raising over $200 million in gross proceeds.
This additional capital will allow us to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage its fantastic science to improve the lives of cancer patients.
For more information, please visit www.iteostherapeutics.com.
ROLE: Regulatory Operations Associate Director
We are building the Regulatory Affairs group at iTeos. We are seeking an experienced Regulatory Operations professional to help us create state-of-the-art regulatory systems and processes, lead submission management activities, and support the Pharmacovigilance group. The candidate will report to the Vice President of Regulatory Affairs and will work in a cross-functional matrix structure with other R&D functions. This is an exciting opportunity for an ambitious and talented regulatory professional wanting to contribute in a meaningful way to the development of innovative IO drugs for cancer patients.
- Develop and maintain submission content plans, track documents from authoring to approval, publishing and QC (US)
- Provide operational oversight for the planning, preparation, publishing, validation and timely submission of applications to global regulatory authorities
- Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies
- Coordinate distribution of submissions to all concerned parties (HA, CRO)
- Provide regulatory operations expertise to global project teams
- Develop, track, and maintain an archive system for worldwide submissions and regulatory correspondences
- Support regulatory intelligence activities
PV operational activities:
- Coordinate and oversee the development and reporting of safety submissions (DSUR, annual safety reports)
- Coordinate and oversee collection, tracking, and maintenance for listings and cases of serious adverse events and events of clinical interest for analysis of up-to-date aggregate PV safety data
- Schedule, coordinate and write minutes for quarterly safety review meetings for clinical programs and ensure that any identified action items are assigned and completed
- Provide safety operational guidance to the development team
- Provide oversight of vendor case management and study support activities
- Lead the development of and oversee the implementation of safety exchange agreements with partners
- Work collaboratively with the PV lead.
- Bachelor's or advanced degree (RN, PharmD) in a scientific discipline or systems technology
- 5-8 years of relevant regulatory operations experience
- Experience in supporting PV operations preferred
- Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
- Extensive knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, eCTD, etc.)
- Knowledge of CDISC (ADaM, SEND, SDTM) preferred
- Thorough knowledge of ICH and GCP requirements
- A demonstrated ability to lead and/or collaborate with groups cross-functionally and problem-solving ability
- Excellent verbal, written, organizational, time management skills with attention to detail
- Excellent document formatting/troubleshooting skills in MS Word, PDF Professional, MS Project
- A stimulating position within a high-potential innovative biotech company
- The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment
- A challenging scientific and business growth in which you get to bring your knowledge and skills
- An attractive salary package in line with the position responsibilities and your experience
Please send your CV together with an adapted cover letter to the following address : firstname.lastname@example.org. Please, mention the reference RO-AD in the mail object. Your application and related information will remain strictly confidential.
For our recruitments, we closely collaborate with a Recruitment & Selection company, Planet Pharma. Your application will be automatically forwarded to them. We, together with Planet Pharma, will keep all your data confidential (GDPR compliant approach).