Eisai
Senior Manager, Biologics CMC Regulatory Affairs
Eisai, Exton, Pennsylvania, United States,
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.Job Summary
Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the preparation of CMC regulatory submissions that meet global regulatory requirements, represents CMC regulatory at team meetings, participates in identification of risk areas, and develops alternative courses of action. Assesses impact of proposed CMC changes on marketed products and evaluates current processes to develop innovative ways to improve efficiency.Essential Functions
Development Projects
Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) prepared in compliance with applicable regulatory requirements and scientific background.Identifies CMC regulatory issues and communicates them to the CMC team to mitigate risk.Prepares original NDAs, MAAs, and Growth Market dossiers ensuring quality documents are prepared.Tracks Module 3 leafs for global submissions.Leads CMC authoring kick-off meetings.Interacts with and influences external stakeholders.Develops regulatory strategy.
Post Approval Projects
Prepares CMC content of post-approval supplements and variations globally; annual reports, product renewals, notifications, and change supplements.Tracks Module 3 leaf changes made as a result of post-approval activity and submissions.Leads CMC authoring kick-off meetings and guides authors regarding necessary Module 3 updates.Interacts with and influences external stakeholders.Evaluates proposed post-approval changes and develops the regulatory strategy.Maintains Agency Approved Module 3 dossiers globally.
Requirements
Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, with a minimum of 8+ years of experience in the pharmaceutical industry.Knowledge and experience of CMC activity in biologics medicine development and post-approval management, and knowledge of health authority guidance and regulations, or strong scientific knowledge of biochemistry, cell biology, or biologic manufacturing.Team leadership in a matrix environment or project management experience preferred.Skills to drive and navigate projects.Knowledge of CTD dossier (module 2.3 and 3).Strategic business thinking.Global organizational awareness.Excellent written and verbal communication skills.Leading change/innovative thinker.
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Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the preparation of CMC regulatory submissions that meet global regulatory requirements, represents CMC regulatory at team meetings, participates in identification of risk areas, and develops alternative courses of action. Assesses impact of proposed CMC changes on marketed products and evaluates current processes to develop innovative ways to improve efficiency.Essential Functions
Development Projects
Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) prepared in compliance with applicable regulatory requirements and scientific background.Identifies CMC regulatory issues and communicates them to the CMC team to mitigate risk.Prepares original NDAs, MAAs, and Growth Market dossiers ensuring quality documents are prepared.Tracks Module 3 leafs for global submissions.Leads CMC authoring kick-off meetings.Interacts with and influences external stakeholders.Develops regulatory strategy.
Post Approval Projects
Prepares CMC content of post-approval supplements and variations globally; annual reports, product renewals, notifications, and change supplements.Tracks Module 3 leaf changes made as a result of post-approval activity and submissions.Leads CMC authoring kick-off meetings and guides authors regarding necessary Module 3 updates.Interacts with and influences external stakeholders.Evaluates proposed post-approval changes and develops the regulatory strategy.Maintains Agency Approved Module 3 dossiers globally.
Requirements
Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, with a minimum of 8+ years of experience in the pharmaceutical industry.Knowledge and experience of CMC activity in biologics medicine development and post-approval management, and knowledge of health authority guidance and regulations, or strong scientific knowledge of biochemistry, cell biology, or biologic manufacturing.Team leadership in a matrix environment or project management experience preferred.Skills to drive and navigate projects.Knowledge of CTD dossier (module 2.3 and 3).Strategic business thinking.Global organizational awareness.Excellent written and verbal communication skills.Leading change/innovative thinker.
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