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
- Manager of Regulatory Operations overseeing eCTD submissions and leading project teams offering regulatory guidance. Responsible for compliance, training, and maintaining stakeholder relationships in healthcare research.
Responsibilities
- Lead the Regulatory Operations project team, providing guidance on regulatory standards, advising on strategies, delivering training, recruitment, workforce planning, and personal development
- Manage eCTD submissions, ensuring they are tracked accurately and in full compliance with regulatory guidelines
- Participate in development of internal processes for eCTD
- Recruitment and training of regulatory personnel for eCTD submissions
- Oversee the global publishing, compilation, filing, and maintenance of regulatory submissions
- Maintain positive and productive relationships with internal and external stakeholders, including regulatory agencies, clients, colleagues, and staff
- Coordinate with country-specific regulatory affairs personnel to support international submissions and registrations
- Engage with regulatory agencies and standards development bodies (such as ICH, CDISC, and HL7) to stay informed about new developments in electronic regulatory standards
- Lead the implementation of new regulatory standards, processes, and SOPs within the department
Requirements
- Bachelor's degree or equivalent experience in a relevant field
- Proven experience working with eCTD submissions
- Demonstrated ability to produce high-quality work with strong attention to detail
- Experienced in creating and delivering effective training materials
- Strong leadership skills with the ability to support and guide team members with both compassion and confidence.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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