Regulatory Affairs Specialist

Job Description

Join a dynamic Regulatory Affairs team that shapes how important medicines reach patients across Europe. As Specialist Regulatory Affairs in our Croatia office, you’ll be the regulatory engine behind product approvals, lifecycle management and label quality. If you enjoy variety, working with cross‑functional teams and making a real impact on public health, this is the role for you.

What You’Ll Do (High Impact):

• Lead submissions and approvals for new Marketing Authorizations for your assigned products, coordinating with local teams and European partners to achieve timely approvals.
• Manage product lifecycles: prepare and submit variations, renewals and supplemental authorizations to keep products on the market and compliant.
• Own labelling quality: translate, QRD‑check and proofread SmPCs, Patient Leaflets and packaging, and manage artwork from mock‑up to final approval.
• Support Clinical Trial Application (CTA) submissions under the new EU CT Regulation and liaise with RAE Liaison and internal stakeholders to accelerate study starts.
• Track regulatory changes, gather regulatory intelligence and translate it into practical guidance for colleagues.
• Maintain excellent relationships with internal regulatory partners and external authorities to ensure smooth reviews and approvals.
• Keep regulatory files, databases and the Artwork Management System accurate and audit‑ready.
• Contribute regulatory input to product launches, promotional reviews and quality/recall actions in partnership with Quality, Medical, Commercial and Supply teams.
• Represent the company in local industry fora and contribute to regional regulatory workstreams.

Who You Are:

• You hold a B.Sc. in Pharmacy, Life Sciences or a related discipline.
• You bring ~2 years’ experience in the pharmaceutical industry (regulatory, medical or lab roles welcome); for senior candidates similar experience in registration/regulatory departments with less supervision is preferred.
• You are fluent in Croatian and English (verbal and written).
• You are meticulous, highly organized and can manage competing priorities under tight timelines.
• You are comfortable with detailed document work and enjoy working across teams to get things done.
• You are IT‑savvy: confident in Word, Excel, databases and online submission systems.

What Success Looks Like:

• Smooth, on‑time submissions for new MAs and post‑approval changes for your product portfolio.
• Clean, compliance‑ready regulatory files and high‑quality translated product information and artwork.
• Trusted regulatory partner for local teams and efficient liaison with regional/global regulatory colleagues.
• Positive contribution to at least one cross‑functional launch or compliance project.

Why Join Us?

• Meaningful work: help bring safe, effective medicines to patients across EMEA.
• International exposure: collaborate with regional and global regulatory experts and gain insight into EU and local regulatory strategy.
• Professional growth: opportunities to take on expanded responsibilities, own projects and participate in regulatory policy activities.
• Supportive environment: cross‑functional teams, structured processes and mentoring by experienced regulatory leads.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

Visa Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(S):

n/a

Required Skills:

Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Issues, Regulatory Policies, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

Job Posting End Date:

10/17/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.