Chargé de la Qualité et Conformité en alternance pour Economie d’Energie. Soutenir la conformité et le contrôle interne tout en participant à la transition énergétique en France.
About the role
- Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.
Responsibilities
- Provide a robust regulatory strategy for assigned products and/or projects, including guidance on maintenance & development needs in the EUCAN region, pediatric development requirements and clinical trial applications.
- Plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region.
- Organize, schedule, and carry out official in-person and remote meetings with regulatory authorities in EUCAN countries.
- Contribute as an active member to the Regulatory Excellence Team meetings and other meetings as required, to support development of worldwide regulatory strategies.
- Act as an interface & contact partner for RA functions in ROPUs and OPUs in EUCAN, Global RA and other cross-functional stakeholders for the assigned marketed products and/or development projects as well as EMA for products under the EU centralized procedure.
Requirements
- Master’s or bachelor’s degree in either pharmacy or life sciences
- Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma; any experience in other functions outside of RA would be highly desirable
- Regulatory affairs 'hands on' experience in the region with an understanding for different cultures and their impact
- Practical experience in handling new developments, registrations, and maintenance of registered products
- Outstanding ability in both negotiating and managing projects paired with knowledge of how to interact with health authorities
- Capability and readiness to apply scientific expertise and participate in informed scientific dialogues
- A critical thinker who has the aptitude to self-manage their workload, which includes the ability to reorganize priorities and meet tight deadlines
- Proficiency in English communication, both verbal and written.
Benefits
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Specialist responsible for corrective actions in Global Trade Compliance at L3Harris. Track compliance incidents and facilitate corrective action processes across US and non - US jurisdictions.
Regulatory Affair Specialist at Capgemini Engineering ensuring regulatory compliance with medical device documentation. Supporting regulatory activities and monitoring the regulatory context impact on site processes.
Compliance Analyst role at Leve Saúde ensuring adherence to regulations in the health sector. Responsibilities include audits, policy management, and due diligence processes.
Governance, Risk & Compliance Specialist at Quilter providing oversight on governance, risk, and compliance activities, strengthening Quilter Invest’s risk management culture across the organization.
Regulatory Specialist responsible for contributions in public consultations and regulatory studies. Engaging with institutional relations and ensuring adherence to energy regulations in Brazil.
Working Student supporting regulatory and compliance efforts at Paymenttools' e - money institution. Collaborating on risk management and compliance projects in a hybrid role based in Cologne.
Senior Consultant Regulatory Affairs participating in pharmaceutical projects focused on market access and regulatory compliance. Joining Deloitte's sector regulation team based in Madrid.
Trade Compliance Officer managing stakeholder compliance with UK and US export laws. Contributing to trade policies and documentation for international imports and exports in a hybrid role.
Expert HSE Compliance role focused on environmental regulations and safety in energy production at EniBioch4in. Overseeing compliance, audits, and promoting HSE culture across facilities.