Job title
: Global Regulatory Continuous Improvement 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 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.
B Corp certified in multiple markets
, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
About The Job
Global Regulatory Continuous Improvement Lead is responsible to ensure continuous improvement of the regulatory activities. Global Regulatory Continuous Improvement Lead ensures the Key Performance Indicators (KPIs), Key Compliance Indicators (KCIs) and other efficiency measures are properly monitored to ensure their compliance with regulatory requirements and their operational efficiency.This role works in close collaboration with the Global Partner Market Team Leads, Manufacturing & Supply Quality Regulatory Lead, Business Process Owners, GRA Global Regulatory Operations (GRO) organization, the Science PV team, the regions and the countries. The Global Regulatory Continuous Improvement Lead will also work closely with the Regulatory & Quality Leads on any performance & continuous improvement topics.
Main Responsibilities
Build a strong continuous improvement strategy to ensure
- Full compliance with applicable regulation, company requirement and also business efficiency
- Performance within the CHC Science Hub Regulatory activities and broader if needed.
- Appropriate centralization and analysis of the KCIs/ KPIs and enhanced related processes for global, regional and country data source.
Based on the CHC Global Regulatory Affairs strategy, the Global Regulatory Continuous Improvement Lead has to design the tactical plan to ensure proper deployment of the continuous improvement plan to
- Monitor the GxP activities and their performance,
- Support and lead solution design/enhancements, global KPIs/KCIs dashboards, process improvement initiatives
- Ensure 100% execution of the accountable tracking plan for CHC Global Regulatory Affairs and its alignment with portfolio activities, targets and objectives at global, regional and country level.
- Identify deviations, associated risks and work with relevant stakeholders to ensure CAPA and mitigation plans.
- Stay current with regulatory knowledge, procedures, and changes, within the CHC Global Regulatory Affairs, and anticipate impact on strategic and performance of Regulatory Business Strategy and Operational Effectiveness
- Communicate metrics as per defined frequencies to the relevant stakeholders/top management (Global Regulatory Affairs, Pharmacovigilance, Evidence Generation, Innovation)
- Interact directly with Opella Key Stakeholders (e.g. GRO) to provide CHC quality KPIs analyses for global reporting to the Senior Management
Continuous Process improvement
- In close collaboration with the Regulatory Business Strategy and Operational Effectiveness Team, and relevant stakeholders, identifies synergies, highlights need for process improvement and lead some actions directly with Global Regulatory Affairs functions Leads, Science Partner Markets, affiliates, and process contacts.
- Promotes best practices, standards, processes and tools in order to ensure business value and compliance through expertise and continuous process improvement.
Training
- Contribute, with the Regulatory Quality Leads, to the process of determining the training needs of the target business teams, ensure compliance and performance.
- Primary interface for any efficiency & continuous improvement topics
- Interfacing across Science Hub, as well as other Global teams and various functions such as PV, GRA, Ethics and Business Integrity (LEBI) etc.
- Transverse leadership role with internal (Global/Regional/Local) and external partners; Governance contact for Regulatory and medical performance topics in transverse meetings and working groups.
About You
Experience:
3-5 years' experience in Pharma industry
- Continuous improvement management
- Knowledge of applicable GxP regulations, guidelines, internal policies, quality systems
- Ability to manage and evaluate complex compliance issues.
- Deliver training to cross functional groups.
- Operate successfully in various team capacities and multicultural environment.
- Proficiency in MS Word, Excel, PowerPoint, planning and analytics skills with willingness to go beyond data policies
Skills
- Ability to develop plans consistent with long-term organizational interests.
- Ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving.
- Ability to continuously improve and develop self.
- The ability to demonstrate support and drive for innovation and organizational transformation.
- Leadership and assertiveness skills
- Internal and external networking capability
- Project management skills
Tools: Power BI, Veeva Vault RIM, Microsoft office suite
Education:
Graduate / Post Graduate degree in life science preferred
Language :
Strong verbal & written communication skills in English
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
