Regulatory Affairs Consultant — Pharma & Biotech (Belgium)

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

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