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