Global Program Regulatory

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- Drive the regulatory strategy, planning and execution across key regions for the assigned development pipeline projects (from early pre-clinical phases)
- Collaborate with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory requirements, supporting the successful development and registration of innovative pharmaceutical products.

Major ActivitiesKey Responsibilities
- Develop and implement Global regulatory strategies for assigned pipeline development programs, ensuring alignment with global regulatory requirements and company objectives.
- Provide regulatory input into R&D; programs to ensure they meet regulatory expectations
- Prepare, review, and manage regulatory submissions including INDs, NDAs, MAAs, ensuring accuracy, completeness, and timely delivery.
- Coordinate responses to health authority queries, ensuring scientifically sound and compliant answers within required timelines.
- Monitor evolving regulatory requirements across major markets (FDA, EMA, ICH,)



and proactively assess their impact on development programs and submission strategies.
- Collaborate with cross-functional teams (R&D;, Clinical Development, CMC, Safety, Quality, business etc ) to ensure integrated regulatory plans
- Support regulatory meetings and interactions with health authorities, including briefing document preparation
- Ensure compliance with internal SOPs and global standards, contributing to continuous improvement initiatives and best practices in regulatory operations.
- Review and approve Clinical Trials Applications (CTAs)
- Perform regulatory Due Diligence activities for acquisition of new assets in development stages to enhance Company pipeline

Job DimensionsIdeal BackgroundDegree in a scientific field
Languages:Fluent in written and spoken English
Experience/Professional requirement:
- More than 5 years of successful managerial experience in the pharmaceutical industry with a proven track record of successful registrati

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7go8du