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Mission Regulatory Affairs Member - Malta

6 days, 18 hours ago
Malta
Contract
Junior
Compliance Manager
Operations
Apply Now
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014
View All Jobs 6

Description

  • Provide local regulatory consultancy and expert advice on marketing authorization applications and amendments.
  • Support the preparation, submission, and follow-up of marketing authorization applications and variations with local Health Authorities.
  • Manage ongoing regulatory activities for authorized products to maintain compliance with national requirements.
  • Support Decentralized Procedure (DCP) lifecycle management and national phase activities.
  • Review product information, labeling, and packaging for alignment with local regulatory standards.
  • Monitor national regulatory changes and communicate relevant updates to stakeholders.
  • Provide ad-hoc regulatory support and guidance as needed.
  • Collaborate with global and regional Regulatory Affairs teams to ensure consistency and compliance.

Requirements

  • University degree in Life Sciences, Pharmacy, or a related field.
  • Minimum of 2 years of relevant Regulatory Affairs experience, preferably in a global or regional pharmaceutical environment.
  • Previous experience with marketing authorization applications, variations, and lifecycle management in Malta is highly valued.
  • Strong organizational and analytical skills with excellent attention to detail.
  • Ability to work independently and collaboratively in a dynamic, multinational context.
  • Proactive, client-oriented mindset with the ability to manage multiple priorities efficiently.
  • Proficiency in MS Windows and MS Office applications.
  • Familiarity with national and EU regulatory systems such as CESP, eCTD, and DCP is an asset.
  • Excellent written and spoken English and local language skills; additional European languages are an advantage.
  • Must be legally able and willing to work as a freelancer and be based in Malta.

Benefits

  • Part-time freelance opportunity based in Malta.
  • Opportunity to work within a dynamic and ambitious Regulatory Affairs team.
  • Exposure to diverse projects through a full-service, functional service provider, and consulting model.
  • Chance to collaborate with preeminent experts across the organization.
  • Environment that encourages growth, innovation, and individual development.
  • Work for a company aiming to become Europe’s leading mid-size CRO.
  • Values-driven culture centered on Audacity, Care, and Energy.

Interested in this position?

Apply directly on the company website

Apply Now

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