Regulatory specialist and senior specialist

Job Title: Regulatory Affairs Specialist Spain
Full Time Permanent
Novumgen is a rapidly expanding, science-driven pharmaceutical company committed to delivering high-quality, accessible medicines across global markets. We are seeking a highly skilled Regulatory Affairs Specialist to support our growing Spanish operation and lead EU regulatory activities.
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. 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. 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.
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.
Lead and manage regulatory submissions and lifecycle activities across multiple EU markets, ensuring full compliance with EMA regulations and national competent authority requirements.
Support cross-border regulatory coordination, ensuring harmonization of product information and compliance with multilingual requirements.
Regulatory Strategy & Compliance
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.
Provide regulatory input into packaging, advertising, and promotional materials to ensure compliance prior to product release.
Review internal practices and recommend improvements to ensure ongoing compliance.
Extensive experience in EU regulatory affairs, including hands-on management of centralized, decentralized, and mutual recognition procedures.
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.
~ Must have fluency in Spanish and English; Strong understanding of scientific and legal principles underpinning pharmaceutical regulation.
Ability to interpret complex technical information and evaluate scientific data accurately.
High attention to detail and a rigorous approach to quality.
Effective organisational and project management skills.
Professional development and career growth opportunities.
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.