Regulatory Affairs Officer (EU/UK/US)

Prothya Biosolutions Belgium BV; Netherlands; Hybride; EUR 52 000 - 75 000; Plein temps

Avantages offerts par ce poste

Holiday allowance

13th month

Personal training budget

Travel reimbursement

Pension plan

Public transport access

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory affairs

GxP knowledge

Stakeholder management

Regulatory submissions

English proficiency

Analytical skills

Project coordination

Independent work

Formation

Master's degree in pharmacy or related field

Description du poste

Prothya is dedicated to ensuring the registration (market authorization) of its medicinal products is obtained and maintained in compliance with regulatory standards. The purpose of your job as Regulatory Affairs Officer is to compile and maintain registration dossiers (EU/UK/US) to ensure that Prothya medicinal products achieve and retain market authorization.

Key responsibilities:

• Compiling and maintaining registration files.
• Perform regulatory submissions to competent authorities (EU/UK/US) required to obtain and maintain marketing authorization for Prothya medicinal products.
• Participate as RA lead in company-initiated projects, collecting and compiling information according to regulatory guidelines.
• Communicate directly with regulatory authorities regarding registration submissions.
• Interpret and implement legislation and regulations for registration dossiers.
• Assess registration dossiers against (inter)national legislation and authorize change controls.
• Initiate the development of and check SPC, package leaflet, box, and label texts in accordance with legislation.
• Assess compliance of marketing materials with the regulatory dossier and national guidelines.
• Advise and support other departments on national and international laws and regulations.
• Maintain overviews of submission status of Prothya products.
• Provide support to Manager RA and Director RA in optimizing processes and systems within the RA department.

Qualifications

• Academic master’s degree in pharmacy or related study such as biochemistry, medical biochemistry, or medicine.

Preferred Skills

• Understanding of existing regulatory GxP requirements.
• Experience in writing GxP documentation such as deviations and change control records.

Required Skills:

• >2 years of experience as Regulatory Affairs Officer EU/UK/US or equivalent.
• Knowledge of relevant (inter)national pharmaceutical legislation and regulations, procedures, products, and (aseptic) production processes.
• Ability to connect diverse topics to present a complete story to the competent authorities.
• Ability to analyze and assess diverse topics and internal documents in relation to applicable registration legislation.
• Ability to work independently and with attention to detail.
• Ability to plan, organize, communicate effectively, and coordinate input from multi-disciplinary teams.
• Ability to identify bottlenecks and suggest improvements or solutions.
• Ability to negotiate with various stakeholders on timelines and content of submissions.
• Ability to build relationships with various stakeholders.
• Fluent written and verbal communication skills in English.
• Act with integrity when dealing with confidential information.
• Ability to handle psychological strain due to peak workload.

What we offer:

• Employment for 36h or 40h with flexible working hours in consultation.
• A salary between€ 4.702,26 and € 6.759,41 gross per month (based on full-time employment)
• A budget of 16,66% (holiday allowance and 13th month) on top of your gross salary, yours to spend or to save monthly
• 30 holiday days (based on fte)
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.