Regulatory Affairs – Waterloo, Belgium (F/M)

Astek Middle East; Waterloo; On-site; CAD 80,000 - 100,000; Full time

Job summary

Astek Middle East is seeking a Regulatory Affairs Consultant to join its consulting team for diverse projects in the pharmaceutical sector. The role requires guiding clients through regulatory processes, ensuring compliance, and contributing to product registrations. Candidates should hold a relevant Master’s degree or PhD and possess strong negotiation and analytical skills.

Benefits

Personalized support for career development

Continuous learning through training programs

Friendly, inclusive work environment

#TopEmployer2025 certified HR practices

Qualifications

• Hold a Master’s degree in Life Sciences or similar.
• Experience in the pharmaceutical sector preferred.
• Fluency in English and French or Dutch is required.

Responsibilities

• Guide clients on regulatory requirements for products.
• Manage product registration and compliance submissions.
• Collaborate with cross-functional teams and stakeholders.

Skills

Negotiation

Analytical skills

Technical writing

Regulatory knowledge

Education

Master’s degree in Life Sciences

PhD in relevant field

Job description

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 report to the Regulatory Strategy Senior Manager.
• Work in cross-functional teams with different departments (manufacturing, labs, QA, supply, etc.) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) to support new product introductions.
• Your hard work and dedication will help our clients achieve new milestones and assist patients worldwide.

Scope Of Work

• Support regulatory submissions (CTD, BLA, NDA, etc.) by informing site colleagues of regulatory requirements and preparing the dossiers.
• Liaise with regulatory colleagues to communicate and resolve potential issues.
• Collaborate with stakeholders to deliver high-quality CMC submissions and ensure compliance.
• Manage responses to health authority requests resulting from lifecycle submissions.
• Assess post-approval changes and related regulatory variations, authoring impacted dossier sections.
• Contribute to project completion, manage own time, and develop work plans within a team.
• Communicate effectively, demonstrating negotiation and influencing skills.
• Be dynamic, flexible, enthusiastic, and eager to learn.
• Work effectively under minimal supervision and in a team environment.

You

• Hold a Master’s degree in Life Sciences (e.g., industrial pharmacy, biomedical sciences, bio-engineering).
• Have experience in the pharmaceutical sector or a PhD with regulatory and quality expertise.
• CMC experience is a plus.
• Possess scientific knowledge and analytical skills with technical writing abilities for regulatory documentation.
• Have knowledge of drug regulations and guidance from agencies like EMA and FDA.
• Be fluent in English and French or Dutch, both written and spoken.
• Have effective communication, negotiation, and influencing skills.
• Be dynamic, flexible, enthusiastic, and eager to learn.
• Be capable of working independently and within a team.

About Alsinova

Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. We offer innovative, customized solutions across various life science segments, including pharmaceuticals, biotech, medical devices, cosmetics, agri-food, veterinary, and healthcare.

Alsinova is a subsidiary of the Astek Group, a global leader in engineering and technology consulting. With a strong culture of entrepreneurship and innovation, our group employs over 10,000 dedicated professionals committed to digital technologies and complex systems engineering.

Join a rapidly growing group with a turnover of 705 M€ in 2024. More information at https://alsinova.com and https://astek.net.

Our Benefits

Choosing Astek means:

• Accelerating your career with diverse assignments
• Accessing exciting projects internally and for clients
• Receiving personalized support for your career development
• Participating in continuous learning through our training programs
• Enjoying a friendly, inclusive environment with #TopEmployer2025 certified HR practices

Let's move forward.