Regulatory Affairs Manager

leading pharmaceutical company

Bratislava

Our client is a leading international pharmaceutical company with a long-standing and successful presence in the Slovak market. With a broad portfolio of both innovative and generic medicines, they are among the leaders in their field, synonymous with quality and innovation. The company is built on a foundation of strong ethical principles and is committed to fostering robust relationships with the healthcare professional community. To strengthen their team, our client is seeking an experienced and proactive Regulatory Affairs Manager (f/m/x). This key position is responsible for ensuring all company activities are in full compliance with current legislation and for managing effective communication with national regulatory authorities, particularly the State Institute for Drug Control (ŠÚKL). Responsibilities:

• Manage all communication with the State Institute for Drug Control (ŠÚKL) and other relevant authorities.
• Oversee the entire product lifecycle from a regulatory perspective, including new marketing authorization applications, variations, and renewals.
• Ensure that all promotional and non-promotional materials comply with legal and regulatory requirements.
• Monitor, interpret, and ensure the implementation of changes in national and EU pharmaceutical legislation.
• Provide expert regulatory advice and strategic support to internal departments, including Marketing, Medical Affairs, and Sales.
• Collaborate on pricing and reimbursement processes.
• Review and approve packaging materials, the Summary of Product Characteristics (SmPC), and Patient Information Leaflets (PIL).

What We Expect:

• A university degree in a Life Science discipline (e.g., Pharmacy, Medicine, Biology).
• A minimum of 5 years of professional experience in a similar Regulatory Affairs role within a pharmaceutical company.
• In-depth knowledge of Slovak and EU pharmaceutical legislation and regulatory processes.
• Fluency in English (both written and spoken) is required.
• Excellent communication, negotiation, and interpersonal skills.
• Strong strategic thinking and complex problem-solving abilities.
• A high degree of autonomy, responsibility, and a proactive mindset.

What We Offer:

• A key, high-responsibility role within a stable, international company.
• The opportunity to directly shape and influence the company's regulatory strategy.
• A professional, collaborative, and dynamic work environment.
• A competitive remuneration package starting from EUR 80,000 p.a. (the final offer will be based on the candidate's experience and seniority).
• A company car (also for private use) and a comprehensive package of attractive benefits.

If you are interested in this challenging position we are looking forward to receiving your comprehensive application for ref.no. 108,036 preferably through our ISG career portal or via email to "pliesovsky@isg.sk".

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Dipl.Ing. Peter Pliesovsky
ISG s.r.o., executive search
Štefánikova 47, SK-811 04 Bratislava 1
T/F: +421 910 600 654
@: bewerbung.pliesovsky@ISG.com