Title: Senior Specialist, Regulatory Submissions Management
Company Summary
One of the most exciting biopharma companies is rapidly growing and developing its teams to carry out the development of its robust T-Cell Therapy ImmunoOncology pipeline. They have proved themselves more than successful with positive readouts over the course of this year and are beginning their BLA preparation in the very near future! A biotech with such potential will not only allow for the mentorship from truly talented professionals, but also career development where you will not find elsewhere.
Overview
We are looking for a detail oriented and personable Senior Specialist of Regulatory Project/Submissions Management who has experience handling and compiling large documents. This individual should also be skilled in formatting and familiar with new and updated processes and software. Lastly, as the newest member of the Regulatory Submission Management team, you will be responsible to jump on board with a knowledge of relevant formatting/document software and take charge in training new hires in this space.
Responsibilities
- Review, compile, and format all Regulatory documents/amendments/submissions
- Format documents into the eCTD format
- Review R&D documents to ensure compliance with standards
- Publish Regulatory submissions, ensuring timely submissions of high quality, compliant, and valid submissions
- Responsible for the accuracy of information
- Coordinate cross-functional timelines to ensure all teams are in alignment
- Work well with multiple projects simultaneously
- Work hands-on in a dynamic fast-paced environment
Experience and Qualifications
- Minimum of 2-4+ years directly related to professional pharmaceutical experience with document management technology and electronic publishing
- Experience with ISI Toolbox, eCTDManager, Veeva Vault, Acrobat, etc.
- Extensive experience with Microsoft software such as MS Word and MS Excel
- Excellent written and oral communication skills
- Ability to work independently and take direction from a mentor
- Interpret Regulatory Affairs documents, submissions, and reports
- Excellent verbal and written communication skills
Education
- Minimum of bachelor's degree or above is required
If you are interested in the Senior Specialist, Regulatory Submissions Management position, do not hesitate to apply!
