WE ARE HIRING!
Regulatory Affairs Specialist
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 Corporate RA Specialist based in Barcelona
(hybrid role)
Your mission:
The main focus of the role is to prepare, manage, and submit regulatory documentation to Health Authorities and customers in both European and non-European markets, ensuring full compliance with regulatory requirements, internal procedures, and quality standards throughout the product lifecycle. In addition, the position provides administrative and technical support for regulatory activities before and after product authorization, supporting the maintenance of marketing authorizations and the management of related variations.
Your major accountabilities:
1. Prepare, manage, and submit Quality and Labelling variation packages, providing regulatory expertise to support product registration and lifecycle management.
2. Review and evaluate regulatory dossiers, including support to technological transfers and updates to pharmaceutical documentation.
3. Compile and manage documentation for Marketing Authorization Transfers (MAT) across multiple markets, in close collaboration with cross‑functional teams (Supply Chain, Commercial, Quality, PV, International Trade).
4. Implement and maintain regulatory dossiers in e‑CTD format, prepare baselines, and ensure accurate updates in the RIM system and internal document repositories.
5. Manage and maintain regulatory records, submissions, and product files to ensure compliance and audit readiness.
6. Act as regulatory liaison with Health Authorities, customers, and external consultants, including preparation and follow‑up of regulatory correspondence.
7. Support submissions, variations, renewals, notifications, and post‑approval activities, including timeline tracking, responses to authority questions, and compliance with post‑approval commitments.
8. Support audits, inspections, and customer requests (due diligences, deficiencies, CPPs, statements, samples), and review and approve artwork to ensure regulatory compliance.
We would like you to have:
9. Minimum 5 years of experience as RA Specialist
10. Experience in Pharmaceutical Industry
11. Strong knowledge of MS Office (Excel, Power Point, Word)
12. Knowledge of database management (Open Text)
13. Knowledge of e-CTD software (Liquent)
14. Strong problem-solving skills and willingness to learn.
15. Good communication and multidisciplinary teamwork abilities with technical and non-technical users.
16. Language: English and Spanish (fluent) and French (desirable)
17. Bachelor’s in pharmacy or chemistry
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:
18. Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
19. Attractive remuneration according to the experience and skills provided.
20. An inspiring leadership team that drives performance.
21. 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:
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.