The Senior International Regulatory Excellence Manager (Senior IREM) supports strategic guidance and regulatory expertise to country regulatory operations across International region with the objective to strengthen and promote compliance with regulatory standards and increase their operational efficiency.
The Senior IREM supports thelocal and regional processes and ways of working across country operations to support increased operational efficiency and regulatory compliance. The Senior IREM leads or support regional regulatory actions required to support business operations. The role provides guidance and support to country organizations on local or regional process redesign and implementation. In partnership with International Regulatory Excellence Director (IRED), global and country roles, the Senior IREM assists with strategic support to the resolution of compliance topics resulting from Quality Events/Incidents, HA inspections and audits as well as for the implementation of preventive risk management measures across countries in the assigned region. The Senior IREM offers global support to country organizations in local health authority inspections and supports implementation and follow up on resulting measures. The Senior IREM partners competently with global roles and represents and/or supports the Senior IRED for the assigned regions in global cross functional initiatives with the goal to ensure that global regulatory processes and tools account for the requirements and business needs of the countries in the assigned regions.
About the Role
Key responsibilities
- Responsible that country/regional regulatory requirements and perspective are represented and acknowledged during global process design or update. Represents RA International countries on global regulatory process review and approval boards, global cross functional initiatives and committees, whenever required.
- Supports a structured network of active stakeholders across International countries and global functions to address potential quality issues / emerging compliance and recommend solutions.
- Provides guidance and support to country operations during design of local or regional processes. Supports countries in evaluating and implementing changes to local or regional processes stemming from various sources, including but not restricted to changes in the regulatory legislation, internal tools and business practices.
- Ensures an up-to-date curricula for regional roles and supports country regulatory teams in designing country level roles and curriculae. Supports initiatives to optimize working models and compliance in their assigned region. Assists implementation of global RA compliance strategies and cross-functions risk management framework across International countries, thereby further supporting the improvement of core business processes at the country level.
- Supports the management of local or regional Quality Incidents/Quality Events - perform investigation, root cause analysis, support CAPA preparation and effectiveness checks across countries in International, as needed. Ensure Inspection readiness. Support to local CO audits / inspection / self-assessment in regions, as needed.
- Responsible for escalating issues to management as necessary and according to process. Oversees regulatory KPI / KQI reports and data analysis received from Global Regulatory Strategic Solutions & Compliance (GRSS&C) and use them to take remediation action on issues or trends across International. Support or lead self-assessments within International RA as needed.
- Utilizes data analyses from global sources on relevant KPIs to support oversight and awareness of local compliance status and issues across the regions and to fuel redesign of working models. Manages follow-up with countries to achieve compliance targets.
- Supports input to development of compliance strategies and risk management framework e.g. via meetings or to the RA Head Pipeline Management, Comp & Ops, enhancing core business processes and considering the individual country regulatory regulations. Provide CO / Regional input to global training requirements and drive country or regional capability enhancing trainings as needed.
Essential requirements
- Requires a Master s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent plus relevant experience and proven skills.
- 12+ years of experience in pharmaceutical Regulatory, QA, Audit/Inspection management support.
- Proven experience in Risk Management, Project Management.
- Wide knowledge and experience of worldwide regulations, guidelines and regulatory processes. Proven ability to drive outcomes in cross-functional teams in a matrix environment.
- Proven records of process simplification and optimization.
- Good analytical skills and ability to understand/predict impact of process and systems
- Proven records of excellent interpersonal communication, influencing and negotiation skills, and proven ability to work effectively in a cross-functional and international matrix environment.
- Proven experience in change management, intercultural experience, and ability to act in a complex and rapidly changing business environment. Strong quality focus, influencing, communication skills, and experience in data analytics and risk management. pharmaceutical or biotech organizations
Desirable requirement
- Prior experience working in pharmaceutical or biotech organizations
