Regulatory Affairs Operations Manager
Job creation – Permanent contract – Full time position
Based in Lyon, France
Reporting to the SVP, Head of Global Regulatory Affairs, based in the US, you will be accountable for providing operational and tactical support to the Project Core Team members for the preparation of regulatory documentation and tracking timelines for clinical trial applications, INDs, IBs, PIPs, DSURs, RMPs, health authority meetings and registration dossiers.
Your main responsibilities are:
- Being responsible for the regulatory submission of CTA for clinical trials
- Prepare/check documentation for initial, ongoing amendments and end of study submissions,
- Monitor Interaction with agencies and Ethics,
- Advise the team on potential regulatory questions/issues,
- Driving the update of regulatory documentation in close collaboration with internal teams and/or external vendors and/or potential partners (IB, DSUR, IMPD, etc.),
- Being responsible for regulatory document's writing and /or reviewing in close collaboration with appropriate internal teams or external vendors (PIP, TPP, RMP, etc.),
- Supporting SVP, Head of Global Regulatory Affairs in preparation and coordination of briefing documents for health Authority meetings (Pre-IND, IND, any other types of meetings) including writing and/or reviewing documents, tracking timelines, deliverables, maintaining risk mitigation plan and management of Q&A to meet agency timelines,
- Participating in clinical, non-clinical and/or core team meetings to provide regulatory guidance and ensure appropriate coordination of all regulatory activities. Provide guidance to the clinical team at each stage of the trials from feasibility to end of study,
- Supporting QA department in the definition or update of QA documents relative to regulatory activities,
- Supporting SVP, Head of Global Regulatory Affairs in coordinating the preparation of marketing authorization applications (MAAs) and New Drug Applications (NDAs) in accordance with requirements set out by regulations and guidelines, in cooperation with external regulatory vendors and/or potential partners, as needed.
You have a Master of Science or equivalent and you are fluent in French and English.
You have a significant experience in the pharma or biotech industry or CRO including exposure to regulatory affairs.
You understand the drug development process and the concepts related to the conduct of clinical trials, including regulatory requirements.
You have knowledge of guidelines/legislation and awareness of regulatory environment in EU and USA.
You have experience in coordinating and editing documents related to product development and Health authority meetings.
You have knowledge of, and experience in, compiling registration documentation for CTA, IND, regulatory dossiers, etc. You already worked with external consultants and vendors.
You are a passionate person who has the ability to facilitate consensus and resolve conflict.
You possess presentation and communication skills and you are used to do writing and reporting.
You have organization skills with an ability to work in flexible environment.
As part of our disability inclusion action plan, our company's hiring policy aims to improve the representation of employees with disabilities in its workforce.
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