Senior Specialist Regulatory Affairs (European Union Countries)

Location: Madrid, Spain; hybrid or remote work arrangements

Company

hirify.global is a global healthcare company focused on women’s health, biosimilars, and access to health solutions.

What you will do

• Coordinate regulatory activities for maintaining existing marketing authorizations and obtaining new authorizations across European markets.
• Prepare, review, and submit post-approval applications, lifecycle management documentation, and new Marketing Authorization Applications.
• Support complex CP, MRP, DCP, NAP, grouping, super-grouping, and work-sharing procedures.
• Develop regulatory strategies, confirm variation classifications, and coordinate labelling variations and product information.
• Prepare responses to Health Authority queries and ensure regulatory milestones are achieved and communicated.
• Collaborate with EMA, country affiliates, regulatory authorities, and regional, global, and cross-functional stakeholders.

Requirements

• University degree in life sciences; pharmacy or pharmacology is preferred.
• At least 5 years of experience in the pharmaceutical industry or a comparable field.
• Extensive experience managing registration processes and European regulatory procedures across multiple markets.
• Fluent written and spoken English is required.
• Experience with regulatory information management systems and tools, including Veeva, Ennov, and Power BI.
• Strong communication, organization, planning, attention to detail, and ability to manage conflicting deadlines independently.

Culture & Benefits

• Regular employment status with one position available.
• Hybrid and remote work arrangements are available.
• Equal treatment and employment opportunities are supported through the local equity plan.
• Travel and credentialing requirements, including applicable vaccination prerequisites, must be met.
• No relocation support is offered.