Regulatory Project Director
il y a 1 jour
We are seeking a highly experienced Regulatory Project Director to join our team at Ividata Life Sciences.
Key Responsibilities:- Manage end-to-end Change Control procedure, including assessment of regulatory impact analysis and preparation of the regulatory package in collaboration with the outsourcing team.
- Oversee Management of Out Of Specification (OOS) for batches under stability.
- Deliver CMC regulatory activities related to progression of clinical programs, including post IND/IMPD submission management.
- Manage and deliver all project management activities to support the CMC pre- and post-approval work of the asset.
- Ensure the necessary regulatory documents are delivered in time and with the adequate quality.
- 10 years of experience in CMC technical roles.
- At least 5 years of experience working on lifecycle management of small molecule products.
- Proven track record of effective stakeholder management across the lifecycle activities of assets.
- Strong project management, organization, and authoring skills.
- Excellent written and spoken English.
Ividata Life Sciences is a leading provider of life sciences solutions. We are committed to delivering high-quality services to our clients.
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Regulatory Project Director
il y a 1 jour
Ris-Orangis, Île-de-France Ividata Life Sciences Temps pleinJob DescriptionWe are seeking a highly experienced Regulatory Project Director to join our team at Ividata Life Sciences.Key Responsibilities:Manage end-to-end Change Control procedure, including regulatory impact analysis and package preparation.Lead OOS management for batches under stability.Deliver CMC regulatory activities for clinical programs,...
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Regulatory Project Director
il y a 1 jour
Ris-Orangis, Île-de-France Ividata Life Sciences Temps pleinJob DescriptionWe are seeking a highly experienced Regulatory Project Director to join our team at Ividata Life Sciences.Key Responsibilities:Manage the end-to-end Change Control procedure, including regulatory impact analysis and preparation of the regulatory package.Collaborate with the outsourcing team to ensure timely and high-quality delivery of...
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Regulatory Project Director
il y a 1 jour
Ris-Orangis, Île-de-France Ividata Life Sciences Temps pleinJob DescriptionWe are seeking a highly experienced Regulatory Project Director to join our team at Ividata Life Sciences.Key Responsibilities:Manage the end-to-end Change Control procedure, including regulatory impact analysis and preparation of the regulatory package.Collaborate with the outsourcing team to ensure timely and high-quality delivery of...
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Regulatory Project Director
il y a 1 jour
Ris-Orangis, Île-de-France Ividata Life Sciences Temps pleinJob DescriptionWe are seeking a highly experienced Regulatory Project Director to join our team at Ividata Life Sciences.Key Responsibilities:Manage end-to-end Change Control procedure, including regulatory impact analysis and package preparation.Lead OOS management for batches under stability.Deliver CMC regulatory activities for clinical programs,...
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