Chief Compliance Officer con inglés (h/m)

Regulatory Affairs Manager

This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.

Are you ready to steer complex, high-impact registrations across international markets and bring transformative medicines to patients with rare diseases? In this role, you will connect science, policy, and business to achieve timely approvals and robust lifecycle management. You will partner closely with global and local stakeholders across development, commercial, and medical functions to expand the reach of our portfolio and maintain compliance at every step. Can you see yourself shaping strategy one day and orchestrating a flawless submission the next?

Submission Planning and Delivery: Build, align, and deliver regulatory submission plans for assigned products and programs across International markets to meet business objectives and accelerate patient access.

Regulatory Compliance Assurance: Maintain rigorous adherence to internal standards, local regulations, and global policies, ensuring inspection readiness and reliable documentation.

Monitor evolving regulations and trends across relevant jurisdictions and development stages, and translate insights into actionable guidance for teams.

Provide regulatory input to Commercial, Medical, and other partners to shape evidence generation, claims strategy, and launch readiness for the International region.

Contribute to internal decision forums and continuously improve regulatory processes, SOPs, and audit/inspection support frameworks.

Opportunity Identification: Identify and prioritize areas where AI tools can streamline workflows, reduce cycle times, and improve submission quality.

Design and validate prompt-based and agentic AI solutions that enhance documentation, planning, and data analysis while meeting regulatory quality and compliance standards.

Bachelor's degree in a relevant field.

• Strong knowledge of drug development and regulatory policy, couple by excellent scientific and business judgment.
• Experience managing regulatory activities in International markets for the global development of products through one or several stages of development including pre-approval and marketed assets.
• Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
• Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.
• Understanding of responsible AI principles such as data privacy, bias mitigation, and compliance requirements relevant to the pharmaceutical and regulatory environment.

Bachelor’s Degree, life science highly desirable.

Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus.

Additional certification and/or training relevant to the role over the past.

That's why we work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. you will find the mentorship, resources, and freedom to explore smarter ways of working—whether you are architecting a pivotal submission package, shaping policy positions, or piloting AI solutions that raise the bar for quality and speed. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy,(including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.