Excelya

Regulatory Affairs Member

Excelya

contract

Posted on:

Location Type: Remote

Location: Malta

Visit company website

Explore more

✨ AI Apply
Apply

About the role

  • Join Excelya, where Audacity, Care, and Energy define who we are and how we work.
  • We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
  • This role is an exciting opportunity to join our dynamic and ambitious Regulatory Affairs team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth
  • The position involves performing as **Local Regulatory Affairs Expert** providing consultancy services related to **marketing authorizations** and supporting regulatory activities for pharmaceutical products in Malta.
  • Work in several aspects of regulatory affairs shall be expected, such as:
  • · 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
  • This position requires solid knowledge of regulatory requirements, strong communication skills, and the ability to work independently while liaising effectively with both local authorities and international teams.

Requirements

  • **Education:****University Degree in Life Sciences, Pharmacy, or a related field.
  • **Experience:****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 Poland is highly valued.
  • **Skills:****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.
  • **Technical:****Proficiency in MS Windows and MS Office applications. Familiarity with national and EU regulatory systems (e.g., CESP, eCTD, DCP) is considered an asset.
  • **Languages:****Excellent command of **English** (written and spoken). Knowledge of additional European languages is considered an advantage.
  • **Soft Skills:****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
  • **Why Join Us?**
  • 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.
  • Here’s what makes us unique
  • 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, allowing you to contribute fully to our shared mission.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Regulatory AffairsMarketing AuthorizationLifecycle ManagementAnalytical SkillsAttention to DetailProficiency in MS WindowsProficiency in MS OfficeKnowledge of CESPKnowledge of eCTDKnowledge of DCP
Soft Skills
Strong Communication SkillsOrganizational SkillsProactive MindsetClient-orientedAbility to Work IndependentlyAbility to Work CollaborativelyAdaptabilitySelf-motivatedTeam PlayerInterest in Regulatory Outcomes