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 Portugal and the wider European region. We are seeking a highly skilled Regulatory Affairs Specialist to support our growing Portuguese operation activities.
Role Overview
The Regulatory Affairs Specialist, based in Portugal will take full ownership of Portuguese regulatory submissions and act as the primary liaison with Infarmed 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.
The successful candidate will have a comprehensive understanding of Portuguese 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 Infarmed, 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 Portuguese regulatory requirements and is updated promptly.
Monitor and interpret changes in Portuguese pharmaceutical legislation and guidelines, providing clear internal guidance on implications for the company's portfolio.
Oversee centralized, decentralized, 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 Infarmed.
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 Portuguese pharmaceutical industry.
Strong knowledge of Infarmed processes and Portuguese regulatory requirements.
Working understanding of EU regulatory frameworks and procedures.
Must have fluency in Portuguese and English; additional European languages are an advantage.
Skills & Competencies
Strong understanding of scientific and legal principles underpinning pharmaceutical regulation.
Ability to interpret complex technical information and evaluate scientific data accurately.
Excellent analytical, problem-solving, and critical thinking skills.
Exceptional written and verbal communication skills for clear, persuasive documentation.
High attention to detail and a rigorous approach to quality.
Strong negotiation and stakeholder management abilities.
Effective organisational and project management skills.
Professional integrity, sound judgement, and a collaborative mindset.
Why Novumgen
Opportunity to play a key role in shaping Novumgen's regulatory presence in Portugal.
A collaborative, mission-driven environment focused on innovation and patient impact.
Professional development and career growth opportunities.
Competitive compensation and benefits.
If you're ready to take the next step in your regulatory career and contribute to a growing global organisation, we'd love to connect.
Apply now and join us in shaping the future of accessible, high-quality medicines.
**PLEASE SEND CV'S IN ENGLISH**