Website Alsinova
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.
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.
- Organized, autonomous, with strong communication skills and attention to detail.
You:
- 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
- Fluent English and French, both spoken and written
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.
- Organized, autonomous, with strong communication skills and attention to detail.
Alsinova
Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions.
Alsinova is the subsidiary of the Astek Group, a global player in engineering and technology consulting. Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its 10.000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.
Join a Group rapidly developing in France and around the world, with a turnover of 705 M€ in 2024.
More on the Group on our websites https://alsinova.com and https://astek.net.
Astek is committed to the employment of people with disabilities.
Our benefits
Joining Astek means choosing:
- an experience accelerator, where every assignment is an opportunity to progress
- access to a multitude of technically exciting projects for our clients as well as internally
- individualized, local support for a tailored career path
- continuous learning, thanks to our internal training academy
- a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices
Let’s move forward.