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Senior Manager, Biologics CMC Regulatory Affairs at Eisai in Woodcliff Lake, New Jersey

Posted in Other 30+ days ago.





Job Description:

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.

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 BLAs, MAAs and Growth Market dossiers ensuring that quality documents are prepared

  • Tracks Module 3 leaf's for global submissions

  • Leads CMC authoring kick off meetings

  • Interacts with and influences external stake holders

  • 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. 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 e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).

  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support for biological products

  • Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.

  • Knowledge of CTD dossier (module 2.3 and 3).

  • Able to deal with issues of critical importance with minimal supervision. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance

  • Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork

  • 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.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

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