Digital Lead for Medical, Regulatory Affairs & Pharmacovigilance Platforms

Opella; Barcelona; Presencial; EUR 90.000 - 150.000; Jornada completa

Descripción de la vacante

Opella in Barcelona seeks a Digital Lead for Medical, Regulatory Affairs & Pharmacovigilance Platforms to shape digital strategy and oversee global platforms. You will guide governance, vendor relationships and platform enhancements across Medical Affairs, Regulatory Affairs, and PV to drive value and compliance.

The role requires strong leadership, strategic thinking, and the ability to manage complex projects with internal and external partners while ensuring adherence to regulatory standards

Formación

• Experience in digital leadership roles within Lifesciences or consumer healthcare.
• Proven experience overseeing digital systems like Medical Affairs event platforms, RIMS and ARIS PV platforms to optimise adverse event monitoring, case processing, and regulatory compliance.

Responsabilidades

• Act as the pivotal link between Global Science-Medical RA & PV functions and technology providers, overseeing delivery of digital solutions.
• Develop and execute a comprehensive digital strategy for Medical, RA and PV platforms, aligning with regulatory requirements.
• Lead discussions on technical feasibility, prototype development, and design of scalable technology solutions.
• Build and lead a high-performing team of digital experts across internal and external resources.
• Manage the execution of the technology roadmap ensuring high-quality, compliant artifacts.
• Drive platform enhancement and optimization for Medical Affairs, Regulatory Affairs and PV platforms.
• Collaborate with Medical Affairs, Regulatory Affairs, PV and other departments to align digital initiatives.
• Oversee application support and vendor management to resolve issues with high stakeholder satisfaction.
• Leverage data analytics to inform decisions and drive continuous improvement.
• Ensure platforms comply with 21 CFR Part 11 and related regulations.

Conocimientos

Leadership

Stakeholder engagement

Communication

Contract negotiation

Problem-solving

Educación

Bachelor’s degree in a relevant field

Master’s degree preferred

Herramientas

ARIS G LifeSphere LSMV

Veeva RIMS

Medical Affairs event platforms

Regulatory information systems

Descripción del empleo

Salary range

All Compensation will be determined commensurate with demonstrated experience.

Job title

Digital Lead for Medical, Regulatory Affairs & Pharmacovigilance Platforms

Location

Barcelona, Spain

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an Digital Lead, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

About the job As the Opella Health and Science Global function within the Digital Division, our mission is clear: we are dedicated to revolutionizing healthcare. We act as strategic partners, providing an organization-wide perspective while effectively utilizing available resources. Our primary focus is on enhancing information systems and refining core competencies in R&D, Regulatory, Sustainability & Packaging, Medical, and Development, all to maximize value for our consumers. Our unwavering commitment to consumer-centric transformation is central to our mission, driving us to improve lives and instigate significant change. By seamlessly merging scientific expertise with consumer insights, we're reshaping our approach to research, development, and the delivery of science-driven solutions that positively impact global health. Our dedication to consumer-centric transformation empowers individuals to actively engage in their healthcare journey and fosters a culture of collaboration, co-creation, and the pursuit of ground-breaking scientific achievements through partnerships with consumers.

Main responsibilities

• Strategic Technology Liaison: Act as the pivotal link between the Global Science- Medical RA & PV functions, and technology providers, overseeing the delivery of digital solutions for Medical, RA & PV information. Establish and maintain strategic vendor relationships and governance structures.
• Digital Strategy: Develop and execute a comprehensive digital strategy for Medical, RA and PV platforms, aligning with organizational goals and regulatory requirements.
• Technical Solutions Leadership: Lead discussions on technical feasibility, prototype development, and the design of efficient, adaptable, and scalable technology solutions, all in adherence to company policies, regulatory standards, and integration goals.
• Team Leadership: Build, mentor, and lead a high-performing team of digital experts (both internal & external) focused on Medical, RA and PV domains, fostering innovation and excellence.
• Technology Roadmap Execution: Manage the execution of the approved technology roadmap, ensuring the delivery of development and validation artifacts to meet high-quality standards, compliance, and audit readiness.
• Platform Enhancement: Drive the enhancement and optimization of digital platforms used in Medical Affairs, Regulatory Affairs and pharmacovigilance, ensuring efficiency and compliance.
• Stakeholder Collaboration: Collaborate closely with Medical Affairs, Regulatory Affairs, PV, Digital, and other relevant departments to align digital initiatives and ensure seamless integration of digital solutions.
• Application Support Management: Supervise both daily and scheduled support for Medical RA & PV platforms collaborating with managed support teams both internal and external eto resolve issues with the highest level of quality and stakeholder satisfaction.
• Vendor Management: Oversee relationships with technology vendors and service providers, ensuring the delivery of high-quality solutions and services.
• Data Insights: Leverage data analytics and insights to inform decision‑making, optimize processes, and drive continuous improvement in Medical, RA and PV operation.
• Regulatory Compliance: Ensure that relevant digital platforms and processes comply with all relevant regulatory requirements, maintaining the highest standards of quality and safety.
• Budget Oversight: Manage the budget for digital initiatives within Medical, RA and PV, optimizing resources for maximum strategic impact.
• Platform Compliance: Collaborate with relevant stakeholders to ensure that solutions, such as Global Safety Database- ARIS G- LifeSphere MultiVigilance (LSMV), Veeva RIMS and Medical Affairs Global HCP Events platform, are developed in line with the requirements of 21 CFR Part 11 and systems validation standards.

About you

Experience Bachelor’s degree in a relevant field; Master’s degree preferred. Proven extensive experience in digital leadership roles within the Lifesciences or consumer healthcare industry. Proven experience in overseeing and implementing digital systems like Medical Affairs event platforms, RIMS and publishing platforms and ARIS or similar PV Platforms to optimize adverse event monitoring, case processing, and regulatory compliance. Strong understanding of Medical affairs, Regulatory Affairs and PV processes. Exceptional leadership and team management skills. Excellent communication and stakeholder engagement abilities. Demonstrated ability in evaluating, negotiating, and managing contracts and Statements of Work with Medical, RA and PV technology vendors and implementation/support providers. Possesses comprehensive knowledge of Quality Assurance and regulatory compliance, including 21 CFR Part 11 and FDA regulations, ensuring technology solutions meet industry standards. Strong problem‑solving capabilities and a track record of successful project delivery. Languages: Advanced English required, Spanish or French preferred Soft skills Strong communication skills tion, negotiation, and interpersonal skills Demonstrated conflict resolution & problem‑solving skills in a global environment. Strong appetite to learn and discover, entrepreneur mindset. Adaptable and open to change Team player, service‑oriented Analytical and synthetic, able to formalize solutions, good writing skills. Strong oral and written communication skills With leadership attitude, autonomy and results driven. Role model our 4 values: teamwork, integrity, respect, courage This is more than the next step in your career, it’s a chance to lead change and help reinvent self‑care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.

About Us

Opella is the self‑care challenger with the purest and third‑largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self‑care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000‑strong global team, our 13 best‑in‑class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.