Regulatory Manager / Senior Regulatory Manager at Jobgether – Spain

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Manager / Senior Regulatory Manager in Spain.

In this role, you will contribute to advancing innovative clinical research programs by shaping and executing regulatory strategies across the drug development lifecycle. You will play a key part in ensuring high-quality submissions to health authorities and ethics committees, supporting clinical trial success in complex therapeutic areas such as oncology and rare diseases. Working within a highly scientific and collaborative environment, you will act as a strategic regulatory partner across global project teams. You will help drive compliance with international regulations while enabling faster and more efficient pathways for life-changing therapies. This position is ideal for a proactive regulatory professional who thrives in fast-paced, cross-functional settings. You will also contribute to continuous improvement initiatives and mentor junior regulatory staff. Your expertise will directly support the delivery of high-impact clinical programs.

• Provide end-to-end regulatory guidance across the clinical development lifecycle, ensuring alignment with applicable global regulations and development strategies.
• Coordinate, compile, and review regulatory submissions including CTA/IND applications, amendments, annual reports, scientific advice packages, orphan designations, pediatric plans, and marketing applications.
• Develop, review, and ensure compliance of regulatory documents submitted to health authorities and ethics committees.
• Act as a regulatory representative in global and cross-functional project teams, including interactions with internal stakeholders and external partners.
• Support or lead regional and global regulatory projects, ensuring timelines, quality standards, and submission targets are met.
• Maintain regulatory project plans, trackers, and intelligence tools while keeping leadership informed of progress and risks.
• Contribute to regulatory strategy development, including timelines for new study opportunities and process improvements across programs.
• Mentor regulatory team members and support capability building within the broader regulatory function.

The ideal candidate brings strong experience in regulatory affairs within a clinical research or CRO environment, along with a solid understanding of global drug development processes. You combine technical expertise with strong communication and organizational skills, enabling you to manage complex submissions and cross-functional collaboration effectively. You are comfortable working in dynamic environments where priorities evolve quickly and quality remains essential. You also demonstrate leadership potential and a proactive mindset toward process improvement and team development.

• Bachelor’s degree (or equivalent experience) in a scientific, pharmaceutical, or healthcare-related discipline; advanced degree preferred.
• 5+ years of regulatory affairs experience for Manager level, 7+ years for Senior Manager level, ideally within a CRO environment.
• Proven experience leading or coordinating clinical regulatory submissions (INDs/CTAs, amendments, scientific advice, and related procedures).
• Strong understanding of global regulatory frameworks, especially EU and/or US drug development requirements.
• Ability to interpret clinical and pre-clinical data to support regulatory strategy and documentation.
• Excellent communication and presentation skills in English, both written and verbal.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Experience collaborating with cross-functional teams and supporting junior staff development.

• Competitive compensation package aligned with experience and seniority level
• Remote or flexible working arrangements depending on project and location needs
• Opportunity to work on innovative clinical programs in oncology and rare disease
• Exposure to global regulatory strategy and high-impact clinical development projects
• Professional development and continuous learning opportunities
• Collaborative, science-driven, and mission-oriented work environment
• Participation in international, cross-functional teams