WE ARE HIRING!
REGULATORY AFFAIRS SPECIALIST - PORTUGAL
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 Regulatory Affairs Specialist based in Portugal/Spain
(remote/hybrid)
Your Mission
- The main focus of this position is to prepare, manage, and submit the documentation required for registration dossiers to the relevant Health Authorities, while ensuring the ongoing maintenance of the company’s marketing authorizations in accordance with quality standards, company policies, and applicable regulatory guidelines and requirements.
- A key objective is to maintain and optimize marketing authorizations throughout the product lifecycle, including the management of variations, renewals, and other post-approval regulatory activities. This involves proactively monitoring regulatory requirements and ensuring timely submissions in line with the company’s regulatory compliance objectives. These activities are essential to maintaining compliance with all applicable regulations and internal procedures.
- The purpose of the Regulatory Affairs Specialist position for our Portuguese affiliate is to provide local regulatory expertise and manage regulatory activities for products authorized in Portugal. In addition, the role is responsible for coordinating regulatory activities with Neuraxpharm partners in Brazil. The position also requires close collaboration with the Corporate Regulatory Affairs team and, when necessary, management of regulatory activities for corporate products.
- The role further includes providing administrative and technical support for regulatory activities before and after the authorization of medicinal products. This includes ensuring compliance with quality standards, company policies, and relevant regulatory requirements, with the objective of obtaining, maintaining, and updating marketing authorizations through the effective management of related variations and regulatory procedures.
Your Major Accountabilities
- Key responsibilities include preparing, managing, and submitting documentation required for registration dossiers to Portuguese Health Authorities, as well as preparing, managing, and submitting Quality and Labelling variation packages. The specialist provides regulatory expertise on submission strategies to support successful product registrations and effective lifecycle management.
- Additional responsibilities include compiling documentation for Marketing Authorization Transfers (MAT) in the Portuguese and Brazilian markets.
- Implementing dossiers in electronic Common Technical Document (eCTD) format, including baseline preparation, and maintaining the Regulatory Information Management (RIM) system. The role also involves maintaining regulatory documentation, submission records, and product files within internal databases and document management systems to ensure compliance and audit readiness.
- Direct communication, negotiation, and liaison with Health Authorities, customers, and consultants are essential aspects of the role. The specialist is responsible for monitoring and evaluating changes in regulatory requirements in Portugal and assessing their impact on business needs.
- Regulatory activities required to maintain registrations in Portugal, including the review and approval of artwork for printing, must be carried out to ensure accuracy and compliance.
- The position also supports the preparation, compilation, and review of regulatory dossiers for submissions, variations, renewals, and notifications. Responsibilities include preparing correspondence with Health Authorities, tracking regulatory timelines, and supporting follow-up activities to ensure submission deadlines are met.
We Would Like You To Have
- Minimum 4years experience in a Regulatory Affairs department of a pharmaceutical company
- Knowledge of Portuguese regulatory processes and national drug legislation.
- Computer literate and proficient use of regulatory databases and systems like MS Office (Excel, Power Point, Word), Database management (RIM), e-CTD software (e-CTD).
- Education: BSc in Pharmacy or Chemistry
- Language: Portuguese and English
- Key Capabilities: Analytical mindset, Results Orientation, Quality orientation, empowerment, Attention to detail, Initiative
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.