Our client, an innovative pharmaceutical company, is hiring a motivated, Senior Regulatory Affairs Associate that will focus on regulatory submissions for global clinical trial applications.
You are a member of the Department Regulatory Affairs / Medical Writing and report to the Director Regulatory Affairs.
You will have a lot of interaction with both external, e.g. regulatory authorities worldwide, and internal parties such as the Business Development, Pharmacology and CMC Department.
The preparation and follow-up of global CTA and IND submissions, incl. responses to Authorities and Ethics Committees are daily business.
In addition, you develop and review the Informed Consent Form .
Keeping oversight on CRO regulatory activities with respect to clinical trial authorizations, including oversight on (e)TMF maintenance, are part of your responsibilities as well.
The CTA and IND submission & approval status as well as regulatory documents needs to be tracked, updated and reported on throughout the product development.
You maintain public study and study results registries.
Furthermore, you are responsible for the review of technical documents incl. protocols, IBs, IMPD, scientific presentations, posters,...
You have a master degree in Medical, Pharmaceutical or Biomedical Sciences and relevant experience in (clinical) R&D within the pharmaceutical industry.
You are familiar with the EU and US regulatory requirements for clinical trials.
English holds no secrets from you and you can effectively and fluently communicate both in writing and orally.
It’s a must that you have a strong sense of accountability.
And finally, if the words: go-getter, organizer, multi-tasker and efficient communicator; cover your personality, you are the (wo)man for this job!
You are offered a permanent, full time contract on the client’s payroll and a competitive salary including an extra-legal package.
And last but not least, you gain experience in an innovative, collaborative and fast moving working environment with room for developing your skills and expertise!
Not yet ready to apply or do you have questions first?
Please give me a call on +32 10 80 71 04, I’ll be happy to give you more information!
Permanent Placement eXPErt