Regulatory affairs officer

Regulatory Affairs Officer – Artwork Management Specialist (Nordic Speakers)

At ALTEN, we drive technological innovation through expertise and collaboration. We are currently looking for a detail-oriented and dedicated Regulatory Affairs Officer specialized in Artwork Management to join our team.

As a Regulatory Affairs Officer, you will play a critical role in ensuring compliance with local and international regulatory standards across various markets.

Key Responsibilities:

• Review and approve artwork to ensure compliance with regulatory standards and requirements.
• Coordinate with internal and external stakeholders, including design, marketing, and packaging teams, to ensure artwork is accurate and meets regulatory guidelines.
• Ensure timely updates of artwork to reflect any regulatory changes, including packaging and labelling components.
• Regulatory Affairs Support:
• Assist in the submission of regulatory dossiers, amendments, variations, and renewals for marketing authorizations.
• Liaise with health authorities and regulatory bodies, providing timely responses to regulatory queries and requests.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• Fluent in Nordic Languages, written and spoken (Mandatory).
• Previous experience in Regulatory Affairs within the pharmaceutical or a related industry, with a focus on artwork management and labelling (preferred), or broader experience in pharmaceutical roles such as QA, QC, or related areas.
• Attention to detail, with the ability to manage multiple tasks and projects simultaneously.
• Excellent communication and collaboration skills, with experience working in cross-functional teams.
• Familiarity with software and tools related to artwork and labelling management is a plus.

Location: Full Remote.

What can we offer you?

• Joining a competitive, multinational company that is constantly growing.
• Integration into a highly qualified team of professionals with a great work environment innovative and dynamic.
• Specialized training and ongoing professional development.
• Social benefits.
• Competitive salary.

Who are we?

We are a team. We are part of ALTEN, a European multinational specializing in providing consulting, information technology, and engineering services to the leading companies in the Portuguese market.

Moreover, at ALTEN, we take pride in offering equal opportunities regardless of gender, age, abilities, or country of origin. Our commitment is to talent and to the people who possess it.