Regulatory Affairs Specialist

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 Burimi: https://mk.linkedin.com/jobs/view/regulatory-affairs-specialist-at-esi-employment-services-international-4412257755

Niveli: senior