Global Regulatory Affairs Lead: Dossier & Submissions

Prothya Biosolutions Netherlands B.V; Netherlands; Hybrid; EUR 52,000 - 75,000; Full time

Benefits offered by this job

Holiday allowance

13th month

Personal training budget

Travel reimbursement

Pension plan

Public transport access

Job summary

Prothya Biosolutions Netherlands B.V. is seeking a Regulatory Affairs Officer to compile and maintain EU/UK/US registration dossiers, ensuring market authorization for Prothya medicinal products.

You will lead regulatory submissions, interact with competent authorities, and guide internal teams on regulatory requirements, timelines, and compliance, while upholding integrity and high attention to detail. The role provides 36–40 hours with flexible working, a hybrid setup, and a competitive

Qualifications

• Master’s degree in pharmacy or related field.
• ≥2 years experience as Regulatory Affairs Officer EU/UK/US.
• Knowledge of inter national pharmaceutical legislation and procedures.
• Fluent English written and spoken.

Responsibilities

• Compile and maintain registration files for EU/UK/US.
• Perform regulatory submissions to authorities to obtain/maintain marketing authorization.
• Lead RA projects and coordinate information according to guidelines.
• Communicate with regulatory authorities regarding submissions.
• Interpret and implement regulatory legislation for dossiers.
• Assess dossiers against regulations and authorize change controls.
• Develop and check SPC, leaflet, box, and label texts.
• Assess marketing materials for compliance.
• Advise other departments on regulatory laws.
• Maintain submission status overviews.
• Support RA Manager and Director in process improvements.

Skills

Regulatory affairs

GxP knowledge

Stakeholder management

Regulatory submissions

English proficiency

Analytical skills

Project coordination

Independent work

Education

Master's degree in pharmacy or related field

Job description

Prothya Biosolutions Netherlands B.V. is seeking a Regulatory Affairs Officer to compile and maintain EU/UK/US registration dossiers, ensuring market authorization for Prothya medicinal products.

You will lead regulatory submissions, interact with competent authorities, and guide internal teams on regulatory requirements, timelines, and compliance, while upholding integrity and high attention to detail. The role provides 36–40 hours with flexible working, a hybrid setup, and a competitive