Excelya logo
Excelya

Expertly delivering clinical trials operations, with care.

Mission Regulatory Affairs Member

ComplianceComplianceContractRemoteMid LevelTeam 501-1,000Since 2014H1B No SponsorCompany SiteLinkedIn

Location

Malta

Posted

91 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

Mission Regulatory Affairs Member

Excelya

Role Description This role is an exciting opportunity to join our dynamic and ambitious Regulatory Affairs team. The role is part-time and involves performing as Local Regulatory Affairs Expert providing consultancy services related to marketing authorizations and supporting regulatory activities for pharmaceutical products in Malta. Furthermore, candidates must be able and willing to legally work as a Freelancer and be based and have experience working in Malta. - Provides local regulatory consultancy and expert advice related to Marketing Authorization (MA) applications and amendments - Supports preparation, submission, and follow-up of MA applications and variations with local Health Authorities - Manages ongoing regulatory activities for authorized products to ensure continuous compliance with national requirements - Provides support for Decentralized Procedure (DCP) lifecycle management and national phase activities - Reviews and ensures alignment of product information, labelling, and packaging with local regulatory standards - Monitors national regulatory changes and communicates relevant updates to stakeholders - Provides ad-hoc regulatory support and guidance as needed - Collaborates closely with global and regional Regulatory Affairs teams to ensure consistency and compliance Qualifications - University Degree in Life Sciences, Pharmacy, or a related field - Minimum of 2 years of relevant experience in Regulatory Affairs, preferably within a global or regional pharmaceutical environment - Previous experience in marketing authorization applications, variations, and lifecycle management in Malta is highly valued Requirements - Strong organizational and analytical skills with a high level of attention to detail - Proven ability to work both independently and collaboratively in a dynamic, multinational context - A proactive, client-oriented mindset and the ability to manage multiple priorities efficiently - Proficiency in MS Windows and MS Office applications - Familiarity with national and EU regulatory systems (e.g., CESP, eCTD, DCP) is considered an asset - Excellent command of English (written and spoken) and local language - Knowledge of additional European languages is considered an advantage - Self-motivated, adaptable, and an effective communicator - A strong team player with a genuine interest in contributing to Excelya’s mission and supporting high-quality regulatory outcomes Benefits At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values of Audacity, Care, and Energy. - We combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare - We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience - Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects - Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey - Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential

Job Requirements

  • University Degree in Life Sciences, Pharmacy, or a related field
  • Minimum of 2 years of relevant experience in Regulatory Affairs, preferably within a global or regional pharmaceutical environment
  • Previous experience in marketing authorization applications, variations, and lifecycle management in Malta is highly valued
  • Strong organizational and analytical skills with a high level of attention to detail
  • Proven ability to work both independently and collaboratively in a dynamic, multinational context
  • A proactive, client-oriented mindset and the ability to manage multiple priorities efficiently
  • Proficiency in MS Windows and MS Office applications
  • Familiarity with national and EU regulatory systems (e.g., CESP, eCTD, DCP) is considered an asset
  • Excellent command of English (written and spoken) and local language
  • Knowledge of additional European languages is considered an advantage
  • Self-motivated, adaptable, and an effective communicator
  • A strong team player with a genuine interest in contributing to Excelya’s mission and supporting high-quality regulatory outcomes

Benefits

  • At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values of Audacity, Care, and Energy.
  • We combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare
  • We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience
  • Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects
  • Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey
  • Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential

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