Regulatory Affairs Contractor
Must be based in Poland or Spain!
Opportunity to contribute to high-impact regulatory submissions in a dynamic, collaborative setting (6 month full-time contract).
Key Responsibilities:
* Support EU regulatory development strategies and execution for key pipeline programs.
* Prepare, submit, and manage CTAs (applications via CTIS) and contribute to the preparation of initial MAAs
* Assist in the development and submission of Paediatric Investigational Plans (PIPs) and full waiver requests.
* Prepare for and participate in EMA and national Health Authority meetings, including Scientific Advice and regulatory briefings.
* Monitor and interpret evolving EU regulatory guidelines relevant to ongoing studies and development plans.
Key Requirements:
* 7+ years of Regulatory Affairs experience in the pharmaceutical or biotech industry.
* Hands-on experience with EU CTAs via CTIS, including submitting initial applications and maintenance.
* Prior experience with MAA submissions, scientific advice and PIPs
* EU regulatory experience essential, US desirable
* Experience working in or supporting small biotech, pharma, or CRO environments and exposure to global team environments