Duke ngarkuar...

Regulatory and Clinical Operations Specialist( Medior Level)

Illyrico Health Data Labs

Tirana, Tirana
full_time
Publikuar 30 dite me pare
**Regulatory & Clinical Operations Specialist (Medior Level)**

**Clinical Trials|PSPs|Biosimilars|Medical Devices|South Eastern Europe| Albania-North Macedonia-Kosovo**

We are a fast-growing, forward-thinking organization working at the intersection of
**clinical research, Health Data Analytics , regulatory affairs, safety, and medical innovation**
. We are looking for a
**medior-level professional who enjoys challenges, learns fast, and wants to grow with the role**
.

This is
**not a static job**
. Your responsibilities will
**evolve step by step**
, giving you increasing ownership as you build confidence, expertise, and impact. You will work closely with experienced team members, but you will also have the freedom to
**take initiative, think independently, and use new technologies – including AI – to achieve outstanding results**
.

**What You’ll Be Working On (and Growing Into)**

Your tasks will expand gradually, based on your experience and interests:

**Clinical Trials & Start-Up**

- Supporting and progressively leading regulatory submissions for clinical trials across South Eastern Europe
- Participating in start-up activities, including initial submissions, amendments, and ongoing regulatory maintenance
- Communicating with Ethics Committees and Competent Authorities, with increasing responsibility over time

**Biosimilar Registration**

- Contributing to biosimilar regulatory activities, from document preparation to authority interactions
- Gaining hands-on experience with lifecycle management and regional regulatory strategies

**Medical Devices & Market Authorisation**

- Supporting interactions with regulatory agencies related to medical devices
- Assisting with market authorisation applications, renewals, and variations

**Visits pharmaceutical clients and prospects**
to promote the company’s services, with focus on Patient Support programs, Local Data Generation, Health Data Analytics , Safety & Medical Information activities, including pharmacovigilance support, compliant medical information handling, and coordination with internal and external partners.May
**afety & Medical Information**

- Supporting pharmacovigilance and safety processes in collaboration with internal and external partners
- Assisting with Medical Information activities, ensuring compliant and timely responses

**Innovation & Smart Ways of Working**

- Using digital tools and
**AI-enabled solutions**
to improve workflows and efficiency
- Actively contributing ideas to simplify processes and raise quality
- Learning how to balance compliance with innovation in a regulated environment

**Who You Are**

- You have
**2–5 years of experience**
in Regulatory Affairs, Clinical Operations, Life Sciences, Pharmacy, or a related field
- You enjoy
**learning by doing**
and are motivated by new challenges
- You are comfortable working in a
**startup-like environment**
, where priorities evolve
- You can work well within a team, but you are also
**not afraid to work independently**
- You communicate clearly and collaborate easily with different stakeholders
- You are curious about
**technology, digital tools, and AI**
, and eager to apply them in real work
- You take ownership, stay organized, and care about delivering high-quality results
- You are fluent in Albanian language
**AND**
English language, a 3rd language would be an asset.

**Why Join Us**

- A
**growth-oriented role**
with responsibilities that expand as you do
- Real exposure to
**clinical trials, biosimilars, medical devices, safety, and medical information**
- A supportive team that values initiative and fresh ideas
- Room to experiment with
**new technologies and AI-driven solutions**
- International scope across
**South Eastern Europe**
- A chance to build a
**meaningful career**
, not just fill a position

If you are a
**medior professional who likes challenges, wants responsibility, and is excited to grow in a startup-style environment**
, we would love to hear from you.

📩
**Apply and grow with us. Send your application by email to jobs@poseidoncro.com before May 15th 2026**