Transparency Officer (Regulatory Affairs)

TL;DR

Transparency Officer (Regulatory Affairs): Managing the anonymisation of personal data and handling commercially confidential information in documents intended for publication with an accent on EU transparency legislation. Focus on assessing CCI/PPD, reviewing document managers' assessments, and ensuring agency compliance with legal transparency obligations.

Location: hirify.global Amsterdam, Netherlands (relocation is mandatory)

Salary: €4,249.97 per month

Company

European Medicines Agency (hirify.global) is a regulatory body ensuring that medicines available on the EU market are safe, effective, and of high quality.

What you will do

• Assess commercially confidential information (CCI) and protected personal data (PPD) using anonymisation methodologies.
• Perform peer reviews of other document managers' assessments of CCI and personal data.
• Analyse new EU legislation to identify transparency requirements and participate in implementation plans.
• Provide scientific input to assist in identifying and locating required documents and data.
• Draft, review, and develop internal and external procedural guidance documents.
• Respond to requests for information (RFIs) in alignment with Agency practice.

Requirements

• Citizen of a European Union Member State, Iceland, Liechtenstein, or Norway.
• English: C1 level required.
• Knowledge of another official language of the European Union (B2 level).
• University degree in Medicine, Pharmacy, Life Sciences, Law, or International Affairs.
• At least 2 years of professional experience in regulatory affairs, pharmaceuticals, biotechnology, or life sciences.
• Mandatory relocation to the Netherlands to take up duties.

Nice to have

• Experience in regulatory affairs of medicinal products.
• Experience working within a multinational team.
• Knowledge of data anonymisation techniques and the development of medicinal products.

Culture & Benefits

• Initial 5-year renewable contract with tax-free salary.
• Household and children's allowances where applicable.
• Expatriation and education allowances and additional home leave.
• Relocation assistance, comprehensive health insurance, and a retirement pension plan.
• Strong work-life balance with flexible working arrangements and teleworking options.

Hiring process

• Shortlisting based on pre-defined questions and application data.
• Preliminary remote assessments including personality (SHL OPQ32) and cognitive tests.
• Final assessments and interviews to determine placement on a reserve list.