21 Regulatory Affairs Ops Specialist Jobs in Round Lake, IL
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Regulatory Affairs Ops Specialist
$73k-96k (estimate)
Full Time
1 Week Ago
SPECTRAFORCE is Hiring a Regulatory Affairs Ops Specialist Near Round Lake, IL
Job Title: Regulatory Affairs Ops SpecialistLocation: Round Lake, IL, 60073Duration: 06 monthsSummary
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 LOA@spectraforce.com if you require reasonable accommodation.
- 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.
- 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.
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 LOA@spectraforce.com if you require reasonable accommodation.
Job Summary
JOB TYPE
Full Time
SALARY
$73k-96k (estimate)
POST DATE
06/22/2024
EXPIRATION DATE
07/18/2024
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