ALSINOVA CRO

Alsinova provides end-to-end life science research services that combine medical expertise with AI-driven tools. As a non-clinical and clinical research company, Alsinova uses a Digital CRO approach, data science, automation, and machine learning to deliver RWE, regulatory affairs, and vigilance support. It operates across 26 countries with flexible collaboration models. Supported by AI and human experts, it tailors solutions for pharma, biotech, and medical device clients. The company targets global life science programs with scalable partnerships.

BioEquivalenceBiostatisticsClinical Data FabricClinical OperationsClinical Project ManagementClinical ResearchConsultingData ManagementData SciencesDecentralized Clinical TrialsDigital EnablementeHealthFSPLife SciencesMedical WritingPhase I to IVQuality AssuranceRegulatoryRWESafetyVigilancealsinova.com

ALSINOVA CRO

HQBoulogne-Billancourt, FR

Team Size216

Open Jobs69

Total Funding-

Latest FundraiseUnknown

Join the Team

Regulatory Affairs CMC Officer - Paris, France (F/M)

HybridParis, Île-de-, FR

Hybrid • Paris, Île-de-, FR

What We Will Accomplish Together Alsinova, the CRO subsidiary of the Astek Group, is currently recruiting a Regulatory Affairs CMC Officer to strengthen its regulatory affairs team and support strategic projects in the pharmaceutical industry.

Your Mission (should You Decide To Accept It) Working closely with our clients in the Life Sciences sector and reporting to the Regulatory Affairs Manager, you will be responsible for CMC-related regulatory activities across the lifecycle of pharmaceutical products. You will play a key role in ensuring the regulatory compliance of technical documentation (CTD Module 2 and 3), defining submission strategies, and coordinating with both internal teams and health authorities.

Teeming tracks opportunities at over 24,000 AI startups, then works with you to find (and land) the one you'll love.

Frontend Developer

Part-timeHamburg, DE

Part-time • Hamburg, DE

DevOps Engineer

Part-timeNiš, RS

Part-time • Niš, RS

Backend Developer

Full-timeBelgrade, RS

Full-time • Belgrade, RS

Technical Writer

InternshipNovi Sad, RS

Internship • Novi Sad, RS

AI Researcher

InternshipNiš, RS

Internship • Niš, RS

Machine Learning Engineer

ContractRotterdam, NL

Contract • Rotterdam, NL

TL;DR

Company Overview

Funding Track Record

Founders

What we do

ALSINOVA CRO

HQBoulogne-Billancourt, FR

Team Size216

Open Jobs69

Total Funding-

Latest FundraiseUnknown

Join the Team

Regulatory Affairs CMC Officer - Paris, France (F/M)

HybridParis, Île-de-, FR

Hybrid • Paris, Île-de-, FR

Teeming tracks opportunities at over 24,000 AI startups, then works with you to find (and land) the one you'll love.

Frontend Developer

Part-timeHamburg, DE

Part-time • Hamburg, DE

DevOps Engineer

Part-timeNiš, RS

Part-time • Niš, RS

Backend Developer

Full-timeBelgrade, RS

Full-time • Belgrade, RS

Technical Writer

InternshipNovi Sad, RS

Internship • Novi Sad, RS

AI Researcher

InternshipNiš, RS

Internship • Niš, RS

Machine Learning Engineer

ContractRotterdam, NL

Contract • Rotterdam, NL

Your Daily Activities Will Be

Analyze CMC regulatory requirements for each product or submission
Contribute to the development and execution of CMC regulatory strategies
Monitor and implement CMC regulatory intelligence and guidance updates
Prepare and write renewal dossiers (MAA – Marketing Authorization Applications)
Draft the CMC sections of Module 2 and 3 in CTD format
Ensure consistency and compliance of the full submission package
Prepare and submit marketing authorization applications (new, variations, renewals)
Interact with Health Authorities and stakeholders throughout submission processes
Gather necessary data and documents from technical departments
Support internal teams with CMC regulatory guidance

Your Future Team You'll join a committed, collaborative and agile regulatory team that values mutual support, scientific rigor, and ownership.

Our consultants work in an environment that promotes expertise sharing, autonomy, and real career development.

You will benefit from continuous support by your manager and a solid onboarding process to ensure a smooth integration.

Master's degree, PharmD or equivalent with specialization in Regulatory Affairs
Minimum 3 years of experience in CMC Regulatory Affairs
Proven experience in drafting CTD Module 2 and 3
Strong background in CMC documentation and writing
Ideally familiar with Veeva Vault RIM or similar regulatory tools
Organized, autonomous, with strong communication skills and attention to detail.
Fluent English and French, both spoken and written

Our Benefits Rejoindre Astek, c'est choisir :

un accélérateur d’expérience, où chaque mission est une opportunité de progresser
un accès à une multitude de projets techniquement passionnants pour nos clients comme en interne
un accompagnement de proximité individualisé pour un parcours professionnel sur mesure
un apprentissage continu, grâce à notre Académie de formation interne
un environnement de travail convivial et inclusif, soutenu par des pratiques RH certifiées #TopEmployer2025 Let's move forward.

We Base Our Relationships On

Respect for employees and clients, and their aspirations,
Personalized support for employees and clients,
Regular career management,
Transparent communication,
Constant responsiveness, availability, and attentiveness.