Associate Director, Commercial Regulatory Affairs
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.
Provide strategic input into the review and approval of effective yet FDA compliant commercial (advertising and promotion) campaigns and pre-commercialization activities. This person will serve as the regulatory lead and on at least two Copy Review Committees (CRCs) which they will Chair, and on the respective Product Medical Review Committees (PMRC).
Manages the advertising and promotion material review and approval process through all product CRCs and the FDA submission process for branded materials.
- As CRC Chair moderate purposeful discussions in a solution-orientated and time-sensitive manner, swiftly lead the committee to consensus on the approval of materials or the need to escalate, ensure that CRC members uphold the Eisai values during CRC meetings and other CRC-related activities, and foster close collaboration with the Business Owner to optimize the quality of the materials and accelerate their review and approval. 25%
- Ensure a highly effective and efficient review and approval process for advertising and promotion materials and the timely and accurate submission of branded materials to FDA in compliance with FDA regulations. 25%
- Recommends best practices and procedures for CRCs including the maintenance of the CRC SWP to ensure the consistency, accuracy and quality of the advertising and promotion review and approval process. 10%
- Oversees training program on the advertising and promotion review and approval process is implemented for all CRC stakeholders, as well as support training on the regulatory requirements for advertising and promotion review and approval and the regulatory landscape. 10%
- Review and approve all advertising and promotional materials, concept reviews and pre-commercialization materials for assigned products in collaboration with commercial, clinical and legal to ensure that they comply with FDA regulations. Provide strategic input into labeling as a member of core labeling development teams. 15%
- Act as liaison with OPDP for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory). 15%
- Minimum Bachelor’s degree or higher in life science
- 10+ years in Regulatory, R&D or related area, at least 5 years of experience in commercial regulatory affairs, labeling or equivalent experience within the pharmaceutical industry.
- Excellent written and oral communication skills, including the ability to train and preset effectively
- Attention to Detail
- Ability to work as a member of a team and collaborate with key cross-functional stakeholders.
- In depth knowledge of FDA regulations and guidance documents regarding advertising/ promotion and labeling requirements
- Demonstrate strong project management, problem solving, strategic thinking, decision making, conflict management, influence, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.
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: https://us.eisai.com/careers-at-eisai/job-detail?searchParam=regulatory&id=JOB_POSTING-3-4381
Job posted: 2020-11-16