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.
The Associate Director will lead the development and implementation of the regulatory strategy, managing the submission content for assigned projects, and support ongoing activities to improve and expand the Regulatory Affairs department. Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics, and devices. Prepares CMC regulatory submissions that meet global regulatory requirements, represents the company during communications and meetings with health authorities. Participates in identification of risk areas and develops alternative courses of action. Assesses impact of new regulations and implements appropriate changes, leads development of company policy and positions on draft regulations and guidance
1. Regulatory 30%:Ensures quality of deliverables and services to stakeholders for multiple projects/product. Take thorough measures to keep Eisai's development projects and established product away from regulatory risk. Provides regulatory consultation to project members.
2. CMC/Quality 40%: Implement regulatory CMC strategy for projects/products. Lead preparation of regulatory communication documents and materials. Attend regulatory meetings to solve issues on CMC/Quality of the development projects. Lead preparation of submission dossier. This includes authoring of QOS. Estimates changes proposed by QA manufacturing and take necessary regulatory measures.
3. Development 30%: Evaluate regulatory CMC situation and propose solutions to make Eisai's CMC activity productive
*Collaborate with biologics process development and analytical operations teams to ensure the use of efficient experimental approaches to facilitate establishment, alignment, and maintenance of biologics drug substance and drug product control strategies to meet current and upcoming regulatory requirements.
*Support subject matter experts (SMEs) in drafting of Module 3 (CMC) sections of clinical trial and marketing authorization applications and supplements (e.g. IND, IMPD, CTA, BLA, MAA, JNDA, CNDA).
*Review draft CMC sections in collaboration with contributors and internal and external stakeholders for the appropriateness and accuracy of technical content.
*Working with regulatory CMC team and SMEs, identify and assess potential regulatory risks and influence teams to formulate phase-appropriate mitigation strategies.
*Support the maintenance of integrated control strategies throughout a program's life cycle.
*Relevant experience is required in executing biologics CMC regulatory strategy for submissions to health authorities in the US, EU and other regions.
This position will report to the Director of Biologics CMC Regulatory Strategy and will be a key contributor in establishing CMC content strategy for each major submission inclusive of development and commercial phase biologics.
*Collaborate with SMEs to author, review, and finalized CMC sections for regulatory submissions.
*Work closely with Regulatory Affairs team to ensure alignment of objectives of submissions and global submission timelines.
*Provide support for cGMP activities as they relate to regulatory affairs submissions: PAI, change control, regulatory assessments.
*Work cross-functionally by attending project teams meetings as needed to support clinical development projects.
*Identify and implement improvements to work processes to optimize productivity, efficiency, and regulatory outcomes.
*Contribute to finalizing a variety of regulatory submissions which include clinical trial and marketing authorization applications and supplements and responses to agency questions.
*A Bachelor of Science degree in a related field with a minimum of ten (10) years of experience in Regulatory Affairs CMC or other relevant industry experience, OR a Master's Degree or other advanced degree and a minimum of eight (8) years of experience in Regulatory Affairs CMC or other relevant industry experience.
*A minimum of three (3) years of relevant experience in biologics drug substance process development, drug product development, or analytical development.
*A minimum of three (3) years of CMC Regulatory Affairs or regulatory technical writing.
*Knowledgeable of regulatory requirements for biologics, including ICH requirements and US regional requirements.
*Able to interpret regulatory requirements and collaborate with biologics development and/or commercial teams to create actionable plans to meet these requirements is required.
*Excellent organizational skills and ability to simultaneously work on multiple projects with defined timeline is required.
*Must work well under deadlines and have excellent attention to detail.
*Excellent verbal and written communication skills and interpersonal skills are required.
Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
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: