Systems Operations Specialist - Regulatory Affairs

Neuraxpharm; Sant Joan Despí; Híbrido; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Neuraxpharm is seeking a Systems Operations Specialist - Regulatory Affairs based in Barcelona, in a hybrid role, to manage regulatory data and support IT integration projects. You will drive accurate data practices and ensure compliance across RA operations, partnering with cross-functional teams and external providers as needed.

The ideal candidate has 5–7 years in regulatory affairs, a scientific degree, and strong experience with eCTD.

Formación

• Regulatory data management and reporting to ensure compliance.
• Support transition to unified regulatory data platform.
• Coordinate with RA and IT on data migration and system integrations.

Responsabilidades

• Implement regulatory data management processes and document control systems.
• Analyze data discrepancies and harmonize information across platforms.
• Maintain databases compliant with PLM, IDMP and other standards.
• Review and harmonize local RA folders across affiliates and update SOPs.
• Collaborate with cross-functional RA teams to meet deliverables and monitor portals/news from agencies.

Conocimientos

Regulatory Operations

Data Management

eCTD

RIM

Regulatory Reporting

Educación

Bachelor's degree in a scientific field

Advanced degree preferred

Herramientas

eCTD software

Regulatory databases

Descripción del empleo

Systems Operations Specialist - Regulatory Affairs

Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause!

Neuraxpharm is looking for a Systems Operations Specialist - Regulatory Affairs based in Barcelona (hybrid role).

Your Mission

The Regulatory Operations Specialist ensures accurate and consistent regulatory data management, supporting analysis, standardization, and reporting to maintain compliance. The role also supports the transition to a unified regulatory data platform, ensuring harmonized data practices, data integrity, and effective coordination across Regulatory Affairs.

Your Major Accountabilities

• Implement the RIM & DMS project on schedule, coordinating with the external provider, and manage electronic document systems to ensure compliant and accessible regulatory records.
• Support RA and IT teams on projects involving data analysis, data migration, and system integrations, identifying discrepancies and aligning data across platforms.
• Maintain regulatory databases and platforms compliant with requirements (PLM, IDMP, XEVMPD), manage Pharmacopoeia updates (BP, EP, USP), and provide regulatory intelligence for decision-making.
• Review and harmonize local RA folders across affiliates, updating SOPs and proposing process/system improvements to enhance data quality, efficiency, and compliance (including KPIs).
• Collaborate with cross‑functional and global RA teams to ensure timely regulatory deliverables and operational alignment, while keeping the organization updated on changes in Agencies’ portals and relevant HA/EMA/CHMP webinars.

We Would Like You To Have

• Basic Bachelor's degree in a scientific or related field; advanced degree preferred.
• Background in Pharmaceutical Companies in a similar Regulatory Operations role.
• Minimum of 5 to 7 years of experience in Regulatory Affairs.
• Proficiency in electronic document management systems (eg eCTD) and regulatory submission software.
• Be a data-driven professional who thrives working with IT systems & databases.
• RIMS (Regulatory Information Management System) knowledge and Reporting tools are preferred.
• Excellent organizational, communication, and problem-solving skills.
• Fluent in English.
• Language: English and Spanish (fluent)

About Us

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 40 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, one in Australia, and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.

Be part of the team where you can count on us to deliver:

• Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
• Attractive remuneration according to the experience and skills provided.
• An inspiring leadership team that drives performance.
• An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert&excellent team!

Interested in knowing more?

Have a look at what Neuraxpharm culture represents and what makes us a great place to work: www.neuraxpharm.com

If you want to join us, this is your opportunity!

WE COUNT ON YOU, YOU COUNT ON US

At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.

We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.

We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.