job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!
location: Deerfield, Illinois
job type: Contract
salary: $45.00 - 51.37 per hour
work hours: 9 to 5
- This role resides within the Regulatory Operations- RA Systems and Submissions Operations organization.
- Drive integration and transition of products into regulatory operation processes.
- Project team member representing Regulatory Affairs Operations, driving timelines and deliverables related to submission documents.
- Primary Regulatory Operations liaison to internal and external groups, including regulatory authorities on electronic submissions and documentation systems.
- Regularly interacts with RA management and functional peer groups inside and outside the department.
- Interacts internally and externally to influence policy and strategy.
- Provide system and process support, development and training.
- Bachelor's Degree or country equivalent with a minimum of 2-3 years in a regulated environment
- Understanding and knowledge of the format and content of regulatory submissions and/or registration documents and associated registration processes
- Hands on experience with electronic submissions and eCTD (INDs, BLAs. NDAs)
- Expert skills in electronic publishing/document/data management systems (e.g. Documentum, ISI Toolbox, eCTD Xpress and database creation/management)
- Sound basis of Regulatory knowledge
- Scientific Knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- Strong oral and written communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
skills: IND, NDA, GCP (Good Clinical Practice), CTD Structure, Regulatory Affairs Operations, Regulatory Briefing Documents
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.