- 経験
- 5年以上
- 給料
- USD 90,000 – USD 120,000 / year
- 求人情報
- 1
- 投稿済み
- 4週間
- 作業モード
- 在任中
- 教育
- Bachelors in relevant scientific discipline
- 資格
- Candidates with a bachelor’s degree or higher in a relevant scientific discipline and at least 5 years of regulatory support experience are eligible, especially those with quality or manufacturing experience in FDA-regulated products.
- 再開する
- 応募必須
勤務地
仕事内容
Role overview
Vector BioMed, Inc. is looking for a skilled Regulatory Affairs Specialist to join its team in Gaithersburg, MD. This role supports regulatory and product development activities for the fast-growing cell and gene therapy space, with a focus on lentiviral vectors used in research and clinical applications. The position is ideal for someone who enjoys working in a fast-paced small-company environment and wants to contribute to the development and commercialization of advanced therapies.
Key responsibilities
- Draft, review, update, finalize, and maintain new and existing Product Master File submissions.
- Coordinate with subcontractors to assemble documents needed for regulatory submissions.
- Advise and support clients preparing filings for the US FDA and other international regulatory bodies.
- Handle communications with regulatory agencies, including meeting requests and responses to requests for additional information.
- Support internal development projects involving advanced therapy medicinal products, including cell and gene therapy programs.
Required background and skills
The role calls for a strong scientific foundation and hands-on familiarity with CMC matters related to biologics, especially advanced therapy medicinal products and cell/gene therapy products. Candidates should understand FDA guidance for biologics and CGT, be comfortable working with the Common Technical Document structure, and have solid experience with cGMP expectations across early to late stages of development and licensure. Strong writing ability, careful attention to detail, and the capacity to communicate effectively in a client-facing setting are important. The ideal person can work both independently and as part of a cross-functional team in a dynamic environment.
Qualifications
A bachelor’s degree or higher in a relevant scientific field is required, along with at least 5 years of experience in a regulatory support position. Experience in quality or manufacturing roles involving FDA-regulated products is also expected.
Compensation
The offered salary range is $90,000 to $120,000 per year, based on experience.
Additional information
This is a full-time, onsite opportunity based in Gaithersburg, Maryland.