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 role
A 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 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 year, a key outcome is to have four priority bioreagents fully characterised, registered in the initial target markets and released under a robust, auditable quality framework.
What you bring
Strong scientific base:
advanced studies in Life Sciences or Bioengineering, or equivalent industry experience, with proven expertise in purification and characterisation of recombinant proteins.
Experience with growth factors or antibodies is a plus, and experience with mammalian systems is highly valued. Ideally a PhD foundation in a field related to mammalian cell culture for high value recombinant protein expression and purification for health-related applications.
2-4 years in regulatory affairs and quality for protein-based products in at least one regulated environment such as cosmetics, IVD or ASR, or medical devices.
Working knowledge of ISO or similar, derived from ISO 9001) and quality tools (risk management, audits, CAPA) and the motivation to adapt them to a new product line rather than a mature, highly standardised setup.
A builder mindset:
curiosity, initiative and the ability to propose solutions when something does not work, not just to execute regulatory/quality existing procedures.
Very good English (spoken and written) to work with international consultants and partners, and Spanish/Catalonian for daily collaboration with the team in Barcelona is a plus.
People who thrive here are proactive, practical and comfortable in a small, fast-moving environment where not everything is defined yet. A \"product fit to market launch\" mindset is mandatory.
How you will work
Location:
Barcelona, in a dynamic biomedical and biotech hub surrounded by other innovative companies and research groups.
Environment:
small, highly qualified team (around 95 % with a PhD) where you see the full product lifecycle, from early development to launch in different markets.
Reporting line:
direct report to the CEO, working closely with the Scientific Director, Operations and, over time, Production and Sales.
Working model:
on-site role with a hybrid flavour, with strong face-to-face collaboration plus some flexibility to work from home by mutual agreement.
On top of this, you benefit from being backed by the stability and benefits of a pharma-style convention, the closeness of a small, supportive team and a culture that values autonomy, trust and work life balance.
Why it matters
This technology aims to replace traditional, animal-derived bioactives/bioreagents in cell culture and related applications with more sustainable and safer, animal-free recombinant products.
You will help make these \"green\" bioreagents acceptable to regulators and customers, so they can reach real labs, clinics and products.
You will also see, in a few years, a breadth of regulatory, quality and product launch experience that many people only see after a decade in larger, more rigid organisations.
If you recognise yourself in this mix of scientific depth, regulatory and quality interest, and appetite to build something new, this role could be a strong next step.
Apply via the Apply button and, if you would like to discuss any point of the offer in more detail, call our Recruiting Manager to talk it through in confidence.