Job Description
Job title Global Regulatory Data & KPIs Team Lead
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 www.opella.com.
Main responsibilities:
- Lead and manage a team of regulatory affairs professionals, including roles focused on electronic documentation, clinical document management, process improvement, data management, and compliance.
- Basic Knowledge of IDMP and XEVMPD
- Provide coaching, mentoring, and professional development opportunities to team members, fostering a collaborative and high-performance work environment.
- Ensure effective resource allocation, balancing workload, and priorities to meet business objectives and regulatory deadlines.
- Oversee the development, validation, and submission of clinical and regulatory documents, ensuring compliance with applicable regulations and internal quality standards.
- Manage the end-to-end process for creating, compiling, and publishing regulatory submissions in electronic Common Technical Document (eCTD) format and other required formats.
- Ensure that all documentation follows established naming conventions, metadata requirements, and other standard operating procedures within the electronic Document Management System (eDMS).
- Develop and implement a robust continuous improvement strategy to enhance regulatory processes, including identifying opportunities for efficiency gains and process optimization.
- Monitor regulatory performance metrics (KPIs/KCIs) and lead initiatives to enhance data quality, compliance, and operational effectiveness across global, regional, and local teams.
- Stay current with evolving regulatory requirements and industry best practices to ensure the company remains compliant and competitive.
- Oversee the strategic development and management of regulatory data and technology, ensuring alignment with business objectives and corporate strategy.
- Manage the deployment of new tools and systems, including Veeva Vault and other relevant technologies, to improve regulatory data management and reporting capabilities.
- Collaborate with IT and other stakeholders to ensure the operational stability and compliance of the regulatory affairs application landscape.
- Act as the primary liaison between Regulatory Affairs, Clinical, Medical Writing, Pharmacovigilance, and other key stakeholders to ensure alignment and effective communication.
- Lead and participate in cross-functional teams and working groups to address regulatory challenges, share best practices, and drive strategic projects.
- Communicate regulatory strategies, process improvements, and compliance updates to senior management and relevant stakeholders.
- Lead strategic projects from initiation to completion, including planning, resource allocation, risk management, and stakeholder engagement.
- Develop and execute change management strategies to support the successful adoption of new processes, tools, and technologies within the regulatory affairs function.
- Provide regular updates on project progress, challenges, and achievements to senior management and other relevant committees.
- Collaborate with Global Science CoE Head to support any additional activities.
About you:
Qualifications:
- Experience Experience in the Pharmaceutical or biopharmaceutical industry, ideally 8+ years in data science, regulatory affairs, or a related field. Proven leadership and team management skills
- Soft skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Proven leadership and team management skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment.
- Technical skills Extensive experience in regulatory data management and compliance. Proven experience in designing and implementing KPI frameworks. Strong analytical skills, with the ability to analyse complex data sets and identify trends and insights. Strong knowledge of regulatory documentation processes, eCTD submissions, data management, and relevant technologies (e.g., Veeva Vault, RIM systems). Familiarity with global regulatory requirements and guidelines.
- Education Master's degree in a scientific discipline, regulatory affairs, or a related field
- Languages Fluent in English (verbal and written)
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.
www.opella.com/en/careers
