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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: Lake Zurich, Illinois
job type: Contract
salary: $75.00 - 83.87 per hour
work hours: 9 to 5
- Serves as the senior regulatory member of the team and may oversee work performed by up to 2 regulatory specialist on the team.
- Represent regulatory in cross functional team(s) and manage actions required of regulatory to bring technical documentation in compliance with applicable regulatory requirements.
- Partner with and provide regulatory support to regulatory contact in the market units.
- Collaborate with program / project managers and other stakeholders to plan, monitor, prepare and track regulatory submissions within established timeline.
- Prepare global regulatory strategies and technical documentation for subsequent submission to regulatory bodies.
- Prepare and ensure official letters and their legalization in accordance with country requirements.
- Coordinate application of government certificates and their legalization according to country requirements.
- Oversee and ensure regulatory documentation is archived according to procedure.
- Oversee and ensure regulatory databases are updated in a timely manner.
- Assure efficient and timely communication throughout projects.
- Bachelor's degree in related field desired
- 5+ years of experience
skills: MS-WORD, MS-EXCEL, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
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.