Regulatory Affairs Specialist - Round Lake, United States - SPECTRAFORCE
Description
Title: Regulatory Affairs Ops Specialist
Duration: 12 Months
Location: Round Lake, IL, 60073
Hybrid - 3 days onsite, 2 remote
Description:
Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
Creating timelines for regulatory filings
Providing and maintain templates for authoring.
Overseeing authoring and reviewing of regulatory documents
QC submission documents
• Contribute to the development of process improvements and procedural documents.
• Identifying and assessing regulatory risks and risks to timelines.
• Providing regulatory updates to the project team on different milestones.
• Working cross functionally with project management, operations, IT and other functions.
• Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
• Working closely with other members of the Regulatory team and provide support to their projects as needed.
• Maintaining archival of submissions and health authority communications in Veeva RIM system.
• Provide regulatory representation on key meetings, including meetings with health agency.
What do you bring:
• Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
• Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
• Excellent written and verbal communication and ability to collaborate across functions.
• Experience with Veeva Vault systems is preferred.
• Strong team player, self-motivated and able to function independently as well as part of a team
• Able to work on multiple projects concurrently and adapt to a continuously changing environment.
• BA/BS in a scientific field and 2-4 years of proven experience
About Us: Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of "human connection," defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $30.00/hr.