Digital Lead for Medical, Regulatory Affairs

Job title: Digital Lead for Medical, Regulatory Affairs & Pharmacovigilance Platforms

• Location: Barcelona, Spain

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: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide.​

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 four 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.​

B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet.​

Find out more about our mission to bring health in your hands at ​

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.

As the Digital Lead for Medical,  Regulatory Affairs & Pharmacovigilance Platforms, you will play a pivotal role in spearheading the implementation and support of digital solutions and informatics systems to facilitate the efficient functioning and continuous enhancement of Medical, Regulatory and Pharmacovigilance operations. This position demands strong strategic leadership, team management, and close collaboration with various departments to optimize regulatory compliance and data management.  

In your capacity as the Digital Lead for Medical, Regulatory Affairs & Pharmacovigilance, you will serve as the key point of contact for business stakeholders in these areas, with the goal of maximizing the value derived from digital investments and technology partnerships. This role requires a comprehensive understanding of Medical, Regulatory Affairs and Pharmacovigilance regulatory frameworks and obligations. It is a highly integrated role, necessitating your ability to influence, negotiate, project plan, and oversee initiatives to drive alignment and performance across the organization.

Success in this position hinges on your enthusiasm, keen attention to detail, and a deep commitment to advancing the quality and safety of all our platforms to benefit patients. You will provide strategic leadership, overseeing a dynamic team and collaborating with cross-functional departments to elevate our digital platforms and operations.

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

Why us?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

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