Senior Manager, Biologics CMC Regulatory Affairs - Eisai
Exton, PA 19341
About the Job
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, represent 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. Evaluates current processes and develops innovative ways to improve efficiency.
Essential Functions
1. Development Projects
- Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) are prepared in compliance with the 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 that quality documents are prepared
- Tracks Module 3 leafs for global submissions
- Leads CMC authoring kick off meetings
- Interacts with and influences external stake holders
- Develops regulatory strategy
2. 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. Guides authors regarding the 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 minimum 8+ years of experience in the pharmaceutical industry
- Knowledge and experience of CMC activity in biologics medicine development and post approval management. Knowledge of health authority guidance and regulations. Or strong scientific knowledge of the biochemistry, cell biology or biologic manufacturing.
- Team leadership in matrix environment or project management experience preferred.
- Skills to drive and navigate project
- 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
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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