Website Alsinova
What we will accomplish together:
Alsinova is looking on a regular basis for Regulatory Affairs Consultants to join our consulting team for clients’ projects (from big pharma to small biotech) based in Belgium.
Your mission (should you decide to accept it):
Your potential challenges will be various, depending on the clients’ priorities. The list below gives you examples of our classic activities.
Your daily activities will be:
- Guide our client by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures.
- Be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Senior Manager.
- Work in cross-functional teams with different departments (manufacturing, labs, QA, supply,…) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) in order to support the introduction of new products at our client’s site.
- It is your hard work and dedication that will make our client ready to achieve new milestones and help patients across the globe.
Scope of work:
- Support regulatory submissions (CTD, BLA, NDA,…) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.
- Liaise with regulatory colleagues to communicate and resolve potential issues.
- Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of our client’s portfolio.
- Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility.
- Assess post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier.
- Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals.
- Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
- Dynamic, flexible, enthusiastic and eager to learn.
- Ability to work under minimal supervision and in a team.
You:
- Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..).
- Experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality.
- CMC experience is a real asset.
- Scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation.
- Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA).
- Fluent in written and spoken English and French or Dutch.
- Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
- Dynamic, flexible, enthusiastic and eager to learn.
- Ability to work under minimal supervision and in a team.
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.
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.