Regulatory Affairs Specialist
ESI (Employment Services International)
/job-details/5980
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Shiko punët aktive.
Regulatory Affairs Specialist
**Role Description**
**ABOUT THE ROLE**
Our client, an international pharmaceutical company, is looking for a motivated Regulatory Affairs Specialist to join their team. If you have a background in life sciences and an eye for detail, this could be your next step.
**KEY RESPONSIBILITIES**
- Preparing, submitting, and tracking Marketing Authorization applications
- Maintaining product licenses through variations, renewals, and supplemental submissions
- Managing labelling, translations, and artwork for assigned products
- Monitoring relevant EU and local regulatory developments
- Collaborating with internal teams and external regulatory authorities
**QUALIFICATIONS & REQUIREMENTS**
- B.Sc. in Pharmacy, Chemistry, or another life science field
- Up to 2 years of experience in the pharmaceutical industry (regulatory, medical, or laboratory setting) — fresh graduates with relevant education are also welcome to apply
- Fluent English, both written and spoken
- Strong computer literacy (MS Office, databases, regulatory systems)
- Exceptional attention to detail and organizational skills
- Willingness to learn and grow within the regulatory affairs field
**WHAT WE OFFER**
- Salary: Aligned with candidate experience and expectations.
- Opportunity to work in a dynamic international environment.
- Professional development and learning in regulatory and administrative processes.
- Supportive team and structured working procedures.
- The position is temporary for 1 year with an option to prolong.
Send us your CV at 📧 rabota@esi.mk or apply directly at 🌐 www.esi.mk
**ESI (Employment Services International)**
Risto Ravanovski St. 2-1/3, 1000 Skopje
📞 T: +389 2 3246-899 | 📠 F: +389 2 3246-897
- 📧 rabota@esi.mk | 🌐 www.esi.mk
**Role Description**
**ABOUT THE ROLE**
Our client, an international pharmaceutical company, is looking for a motivated Regulatory Affairs Specialist to join their team. If you have a background in life sciences and an eye for detail, this could be your next step.
**KEY RESPONSIBILITIES**
- Preparing, submitting, and tracking Marketing Authorization applications
- Maintaining product licenses through variations, renewals, and supplemental submissions
- Managing labelling, translations, and artwork for assigned products
- Monitoring relevant EU and local regulatory developments
- Collaborating with internal teams and external regulatory authorities
**QUALIFICATIONS & REQUIREMENTS**
- B.Sc. in Pharmacy, Chemistry, or another life science field
- Up to 2 years of experience in the pharmaceutical industry (regulatory, medical, or laboratory setting) — fresh graduates with relevant education are also welcome to apply
- Fluent English, both written and spoken
- Strong computer literacy (MS Office, databases, regulatory systems)
- Exceptional attention to detail and organizational skills
- Willingness to learn and grow within the regulatory affairs field
**WHAT WE OFFER**
- Salary: Aligned with candidate experience and expectations.
- Opportunity to work in a dynamic international environment.
- Professional development and learning in regulatory and administrative processes.
- Supportive team and structured working procedures.
- The position is temporary for 1 year with an option to prolong.
Send us your CV at 📧 rabota@esi.mk or apply directly at 🌐 www.esi.mk
**ESI (Employment Services International)**
Risto Ravanovski St. 2-1/3, 1000 Skopje
📞 T: +389 2 3246-899 | 📠 F: +389 2 3246-897
- 📧 rabota@esi.mk | 🌐 www.esi.mk
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