Senior Regulatory Affairs CMC Specialist We are seeking a highly experienced Regulatory Affairs professional with deep Chemistry, Manufacturing & Controls (CMC) expertise to support global regulatory activities across a diverse and innovative product portfolio.

The successful candidate will play a critical role in defining global regulatory strategies, leading complex submissions, and driving effective engagement with international health authorities to support product development, approvals, and lifecycle management. You will be joining our team in Barcelona, working on a hybrid basis.

Global Regulatory Strategy & Submissions

Develop and execute global regulatory strategies informed by regulatory intelligence, product development goals, and evolving health authority expectations.

Lead regulatory submission planning and oversee the preparation, compilation, review, and maintenance of high-quality regulatory dossiers.

Manage general submissions and associated activities, including:

Marketing Authorisation Applications (MAA), New Drug Applications (NDA), and Biologics License Applications (BLA)

Clinical Trial Applications (CTA) and Investigational New Drug applications (IND)

Medical device submissions, CE marking activities, and Notified Body interactions

Site Master Files

Renewals, post-approval variations/changes, commitments, and ongoing lifecycle management activities

Coordinate responses to health authority questions and ensure timely delivery of high-quality regulatory responses.

Health Authority Engagement

Plan, lead,



and support strategic interactions with global health authorities.

Prepare meeting requests, briefing packages, and facilitate preparation activities for regulatory meetings.

Capture, communicate, and drive actions resulting from formal health authority interactions.

Provide regulatory guidance and support to regional teams preparing for authority engagements.

Cross-functional Leadership & Collaboration

Act as a key member of global Regulatory Affairs matrix teams, ensuring alignment across functions and geographies.

Provide strategic regulatory input into development plans, timelines, and business decisions.

Facilitate clear communication and effective collaboration between internal teams, external partners, and regional stakeholders.

Regulatory Excellence & Process Improvement

Drive continuous improvement initiatives across regulatory processes, documentation standards, and strategic planning approaches.

Contribute to the optimisation of regulatory ways of working and best practices.

Regulatory Due Diligence & CMC Assessment

Lead regulatory due diligence activities for development programmes and portfolio opportunities, including:

Assessment of CMC data packages and manufacturing development strategies.





Identification of regulatory risks, gaps, and mitigation plans.

Evaluation of product positioning, development pathways, and external regulatory considerations.

Lead the overall regulatory CMC and device strategy across assigned products and programmes, including combination and device-related products.

Partner with global and regional teams to ensure successful and timely execution of regulatory plans.

Communicate strategic decisions, emerging risks, dependencies, and resource considerations to key stakeholders.

Essential Experience & Skills

Approximately 8 - 10 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, or related life sciences industry.

Advanced expertise in CMC regulatory requirements, with a strong understanding of global regulatory frameworks across the US, EU, Japan, China, and other major markets.

Broad experience supporting products through all phases of development, registration, and post-approval lifecycle management.

Demonstrated success in developing and executing global regulatory strategies and managing complex submissions and health authority interactions.

Strong experience authoring and reviewing Module 3 CTD documentation.

Excellent stakeholder management, communication, and influencing skills, with the ability to work effectively across global, cross-functional teams.

A strategic, proactive, and solutions-oriented mindset, with the ability to manage competing priorities in a dynamic environment.

📌 Regulatory Affairs CMC Specialist (Madrid)
🏢 Gu0026L Scientific
📍 Madrid