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 📧 [email protected] 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

• 📧 [email protected] | 🌐 www.esi.mk