Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist Spain

Full Time Permanent

Location: Spain (Madrid)

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 Spain and the wider European region. We are seeking a highly skilled
Regulatory Affairs Specialist
to support our growing Spanish operation and lead EU regulatory activities.

Role Overview

The Regulatory Affairs Specialist, based in Spain, will take full ownership of Spanish regulatory submissions and act as the primary liaison with AEMPS, ensuring compliance with all national requirements. In addition, this role will lead regulatory activities across EU markets, managing submissions and lifecycle processes in alignment with EMA and national competent authority regulations.

The successful candidate will have a comprehensive understanding of Spanish pharmaceutical regulations and marketplace dynamics, alongside deep expertise in EU regulatory frameworks, 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

Spain-Focused Regulatory Activities

• Prepare, compile, and submit high-quality regulatory dossiers to
  AEMPS
  , including new marketing authorisation applications, variations, renewals, and post-approval updates.
• Act as the primary liaison with Spanish regulatory authorities, managing communications and coordinating responses to queries and deficiency letters.
• Ensure all product information complies with Spanish regulatory requirements and is updated promptly.
• Monitor and interpret changes in Spanish pharmaceutical legislation and guidelines, providing clear internal guidance on implications for the company's portfolio.

EU Regulatory Leadership

• Lead and manage regulatory submissions and lifecycle activities across multiple EU markets, ensuring full compliance with EMA regulations and national competent authority requirements.
• Oversee centralized, decentralized, mutual recognition, and national procedures, providing strategic input to optimize timelines and approvals.
• Ensure adherence to key EU directives and regulations.
• Manage product lifecycle activities, including renewals, variations, safety updates, and labelling changes across EU territories.
• Support cross-border regulatory coordination, ensuring harmonization of product information and compliance with multilingual requirements.
• Monitor and interpret changes in EU pharmaceutical legislation and guidelines, providing proactive internal guidance and risk assessments.

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

• Extensive experience in EU regulatory affairs, including hands-on management of centralized, decentralized, and mutual recognition procedures.
• Proven track record of successful submissions to AEMPS and other EU national authorities.
• 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

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• 3–5 years of experience in Regulatory Affairs within the Spanish pharmaceutical industry.
• Strong knowledge of AEMPS processes and Spanish regulatory requirements.
• Working understanding of EU regulatory frameworks and procedures.
• Must have fluency in Spanish 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 Spain and across Europe.
• 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.