Regulatory Affairs – Waterloo, Belgium (F/M)

Alsinova; Waterloo; Sur place; EUR 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

Career development

Challenging projects

Tailored career path

Continuous learning

TopEmployer HR practices

Résumé du poste

Alsinova, part of the Astek Group, is actively seeking Regulatory Affairs Consultants to support clients in Belgium. You will work across projects from small biotech to large pharma, handling regulatory submissions and liaising with EMA/FDA guidelines.

The role involves CMC considerations, cross-functional collaboration, and delivering high-quality regulatory documentation. Candidates should have a master’s degree in life sciences, expertise in regulatory and quality domains, and fluency in

Qualifications

• Experience in pharmaceutical regulatory affairs and quality is preferred.
• CMC experience is a real asset.
• Knowledge of EMA/FDA guidelines and regulatory processes.

Responsabilités

• Interpret federal, state and international regulations as they apply to products.
• Author regulatory dossiers and manage submissions (CTD, BLA, NDA) with cross-functional teams.
• Collaborate across departments to support product introductions and lifecycle changes.
• Communicate clearly with stakeholders and respond to regulatory requirements in a timely manner.

Formation

Master degree in Life sciences

Description du poste

What we will accomplish together:

Alsinova is looking on 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 clientby 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 clientready 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 – An Astek Company

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 730 M€ in 2025.

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 #TopEmployer2026 certified HR practices

Let’s move forward.