Regulatory and Quality Manager (Barcelona)If you can read a protein gel as easily as other people read LinkedIn, this will speak your language.Building regulatory and quality compliance from scratch for a new line of green biologic actives sounds more exciting to you than adding one more already approved ingredient to a dossier? Then keep reading.The roleA fast-growing biotech company in Barcelona is launching a new line of recombinant green (animal-free) growth factors and related biologic actives for cell culture and dermo-cosmetic applications, produced with a proprietary vegetal cells expression platform. They are hiring their first Regulatory and Quality Manager to make this new portfolio “reg-ready” to sell in different life-science markets.You will design and implement the regulatory and quality framework for this product line and become the main internal reference for compliance topics, working directly with the CEO and senior scientific and operations leaders.What you will do
Define development and quality requirements (purity, characterisation, release specs) so new bioreagents can be launched first in cosmetics and cell-culture markets, and later in medical devices, IVD or ASR and pharma.
Prepare and manage regulatory filings for bioreagents (for example INCI registrations, ASRs or IVD, DMFs) and interact with agencies such as EMA, FDA and other authorities when needed.
Build, implement and maintain an ISO 13485 (or similar, derived from ISO 9001) compliant QMS for this line, including risk management, internal audits, CAPA, product release and documentation control.
Work closely with R&D;, Production (internal and CMOs) and Commercial so that what is written in datasheets, claims and technical files truly matches regulatory compliance for each target market .
Own regulatory and quality documentation for the line: technical files, validation reports, registrations, audit reports and submission history.
In the first yea