Senior Drug Registration Specialist

Poland, Warszawa

Pharmacy

Permanent Work

Employment Contract

negotiable

Publication date:
16/06/2025

Job description

For our client - a Polish company with an established position in the European drug distribution market - we are looking for a Senior Drug Registration Specialist

This is a new role in the organization's structures, created for an experienced professional who combines knowledge of regulatory regulations with a passion for developing pharmaceutical products in the Polish market.

What We're Looking For

Opportunity to take on a new position with real impact on the development of the company's product portfolio.
Cooperation with foreign partners in an international environment.
Participation in shaping the product strategy and development of the company.
Hybrid work model - flexible combination of remote and stationary work.
Flexible terms of employment - employment contract or B2B, depending on your preferences.
Benefit package: private medical care (Medicover), Multisport card.

Your Responsibilities

Preparation of registration dossiers (CTD/eCTD) in accordance with URPL requirements and EU regulations.
Coordination of national registration processes - for products intended exclusively for the Polish market.
Verification of the correctness of documents provided by foreign manufacturers.
Monitoring legislative changes in Poland, EU and third countries (China, India, Turkey, Brazil).
Cooperation with regulatory institutions (URPL, GIF).
Participation in international pharmaceutical fairs (e.g. CPhI), building relationships with new partners and evaluating their products.
Assessing product compliance with quality, regulatory and legal requirements.
Supporting post-registration processes (amendments, renewals, MAH transfers).

What We Offer

Master's degree in Pharmacy, Chemistry, Biotechnology or related fields
Minimum of 4-5 years of experience in Regulatory Affairs - experience with non-EU imported products preferred.
Experience in dealing with foreign drug manufacturers and suppliers.
Knowledge of English language level C1/ C2 - professionally fluent.
Excellent knowledge of Polish and EU regulations on registration of medicinal products and procedures of cooperation with URPL.
Ability to analyze registration documents, verify quality and clinical data and product life cycle management.
Knowledge of pharmaceutical law, EMA, ICH guidelines and EU regulations.
Practical experience in preparation of registration dossiers (CTD, eCTD), cooperation with URPL and assessment of compliance with GMP, GDP, GVP.

Looks interesting?

Apply

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