Regulatory Affairs Specialist

About Novumgen

Novumgen is a rapidly expanding, science-driven pharmaceutical company committed to delivering high-quality, accessible medicines across global markets. Our diverse portfolio spans specialty generics, complex formulations, and innovative therapeutic solutions. With a strong focus on regulatory excellence, scientific integrity, and patient impact, we are strengthening our presence in Poland and the wider European region. We are seeking a highly skilled Regulatory Affairs Specialist to support our growing Polish operation activities.

Role Overview

The Regulatory Affairs Specialist, based in Poland will take full ownership of Polish regulatory submissions and act as the primary liaison with Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) ensuring compliance with all national requirements. In addition, managing submissions and lifecycle processes in alignment with EMA and national competent authority regulations. You will previously have been a pharmacist and be able to approve and sign off marketing material.

It is essential that the successful candidate will have a comprehensive understanding of Polish pharmaceutical regulations and marketplace dynamics, including centralized, decentralized, and mutual recognition procedures. This position requires strong analytical skills, the ability to interpret evolving legislation, and a proactive approach to regulatory strategy. Working cross-functionally, the Regulatory Affairs Specialist will ensure that Novumgen’s products remain compliant, safe, and high-quality throughout their lifecycle, while driving efficiency across multiple jurisdictions.

Key Responsibilities

Regulatory Activities

• Prepare, compile, and submit high-quality regulatory dossiers to URPL, including new marketing authorisation applications, variations, renewals, and post-approval updates.
• Act as the primary liaison with Portuguese regulatory authorities, managing communications and coordinating responses to queries and deficiency letters.
• Ensure all product information complies with Polish regulatory requirements and is updated promptly
• Monitor and interpret changes in Polish pharmaceutical legislation and guidelines, providing clear internal guidance on implications for the company’s portfolio.
• Oversee centralised, decentralised, mutual recognition, and national procedures, providing strategic input to optimize timelines and approvals.
• Support cross-border regulatory coordination, ensuring harmonization of product information and compliance with multilingual requirements.

Regulatory Strategy & Compliance

• Ensure all Novumgen products comply with regulatory requirements in their respective markets.
• Develop scientifically sound arguments and justifications to support new product licences, renewals, and variations.
• Provide strategic regulatory advice to senior management, R&D, Quality, and Manufacturing teams throughout product development and lifecycle management.
• Participate in change control processes, assessing regulatory impact and ensuring appropriate documentation and submissions.

Data Evaluation & Documentation

• Collect, analyse, and evaluate scientific, technical, and clinical data to support regulatory submissions.
• Prepare high-quality regulatory documentation, ensuring accuracy, consistency, and compliance with applicable guidelines.
• Maintain regulatory files, databases, and tracking systems to ensure accurate, up-to-date information on approvals and submissions.

Cross-Functional Collaboration

• Act as a regulatory liaison between internal teams, ensuring timely communication of requirements, risks, and expectations.
• Provide regulatory input into packaging, advertising, and promotional materials to ensure compliance prior to product release.

Authority Interaction & Inspections

• Liaise with regulatory authorities, prepare formal presentations, and support negotiations for marketing authorisations.
• Assist in preparation for and management of regulatory inspections and audits.
• Review internal practices and recommend improvements to ensure ongoing compliance.

Candidate Profile

• Able to sign off and approve marketing materials
• Proven track record of successful submissions to URPL
• Strong understanding of EMA processes, EU directives, and regulatory frameworks.
• Excellent communication and stakeholder management skills.
• Ability to interpret complex regulations and provide strategic guidance.

Qualifications

• Qualified pharmacist with ability to sign off documents
• 3–5 years of experience in Regulatory Affairs within the Polish pharmaceutical industry.
• Strong knowledge of URPL processes and Polish regulatory requirements.
• Working understanding of EU regulatory frameworks and procedures.
• Must have fluency in Polish and English; additional European languages are an advantage.