Pharma Regulatory Affairs Consultant – CTD/BLA

Alsinova; Belgique; À distance; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Experience accelerator

Training academy

TopEmployer practices

Résumé du poste

Alsinova seeks Regulatory Affairs Consultants to join our Belgium-based team on a regular basis for client projects across pharma and biotech. You will interpret global regulations, author regulatory dossiers, and collaborate with R&D, QA and manufacturing to support new product introductions at client sites.

The role emphasizes CMC experience, scientific writing, and strong communication in English and either French or Dutch.

Qualifications

• Experience in regulatory (CTD, BLA) and quality in pharma.
• Knowledge of EMA/FDA guidelines.
• CMC experience is a real asset.
• Strong writing and analytical skills for regulatory documentation.

Responsabilités

• Interpret regulations for products, processes and procedures.
• Lead regulatory submissions and dossier authoring.
• Collaborate with cross-functional teams (manufacturing, QA, R&D).
• Communicate regulatory requirements to site colleagues.
• Respond to health authorities during lifecycle submissions.

Connaissances

Regulatory affairs

Technical writing

Regulatory guidance

Communication

Team collaboration

English (fluent)

Formation

Master degree in Life sciences

Description du poste

Alsinova seeks Regulatory Affairs Consultants to join our Belgium-based team on a regular basis for client projects across pharma and biotech. You will interpret global regulations, author regulatory dossiers, and collaborate with R&D, QA and manufacturing to support new product introductions at client sites.

The role emphasizes CMC experience, scientific writing, and strong communication in English and either French or Dutch.