Emplois actuels liés à Global Regulatory Strategist - RisOrangis, Île-de-France - Ividata Life Sciences

Job Title: Global Regulatory Lead

Company: Ividata Life Sciences

Leadership on Regulatory Strategy:

• Develop and implement regulatory strategies to ensure compliance with global regulatory requirements.
• Collaborate with cross-functional teams to create and maintain the product's global regulatory strategy aligned with the Regulatory Strategy Document.
• Accountable for ensuring collaboration across internal stakeholders to create and maintain the product's global regulatory strategy.
• Develop and maintain relationships with key stakeholders, including Health Authorities, to ensure successful regulatory submissions.
• Lead the development of regulatory documentation, including CTA/IND documents, core briefing books, and slide sets.
• Provide support to RRL/LRA in key markets to facilitate registration procedures.
• Provide support to Market Access in key markets for the core value dossier.
• Primary point of contact for all internal communications regarding project status on regulatory processes, strategy, and delivery.
• Interface with external partners, including CDx providers and licensing partners.

Education and Experience:

• Advanced degree in a relevant scientific discipline or equivalent experience.
• Minimum of 5 years' experience in managing regulatory processes and registration aspects of the drug development process.
• Prior experience as an experienced Global Regulatory Lead is preferred.
• Experience with ICH, FDA, and EMA guidelines and requirements is essential.
• Fluent in English, with good knowledge of French an advantage.

Key Skills:

• Strong leadership and collaboration skills.
• Excellent communication and project management skills.
• Ability to successfully prioritize multiple global tasks, projects, and objectives within a defined portfolio.
• Strong analytical and problem-solving skills.
• Ability to work in a fast-paced environment and adapt to changing priorities.