Senior Specialist, Regulatory Registration and Compliance

ERGOMED

Senior Specialist in Regulatory Registration and Compliance managing marketing authorization submissions for PrimeVigilance. Collaborating with regulatory authorities and clients to ensure compliance and provide regulatory advice.

Posted 6/27/2026full-timeRemote • 🇭🇷 CroatiaSeniorWebsite

About the role

Key responsibilities & impact

Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation.
Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle.
Review and provide linguistic input for local Product Information and Mock-ups.
Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients.
Involvement in project management of the network of local contact persons for Regulatory affairs.
Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes.
Propose marketing authorization strategies tailored to client needs.
Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.

Requirements

What you’ll need

University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology
Previous industry experience is essential
Knowledge of Regulatory area and applicable legal and other requirements (both local and global) within pharmaceutical industry
Excellent organizational skills with the ability to manage multiple projects and deadlines.
A collaborative mindset, coupled with excellent communication skills to liaise with clients and regulatory bodies effectively.
Advanced knowledge of English (both written and verbal)
Experience with centralised procedures advantageous
Experience with regulatory databases and dossier management software advantageous

Benefits

Comp & perks

Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsquality controlregulatory intelligenceproject managementdossier management

Soft Skills

organizational skillscommunication skillscollaborative mindsetleadership