Job Details
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Posted 1 week ago
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Job Id: JN -122025-561205
Regulatory Affairs Analyst
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McLean, Virginia
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Contract
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Hybrid
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25
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/hr
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Job Description
Regulatory Affairs Specialist
Remote
1-YR Contract (Possbility of extention)
PR: $60 – $70/hr
Virginia, USA
Overview:
Our client is seeking a Regulatory Affairs Specialist to assess and enhance regulatory affairs processes, focusing on the preparation and submission of PMTA and SE applications in compliance with FDA requirements. In this role, you will conduct current state assessments, develop detailed process flow documentation, identify gaps or inefficiencies, and recommend modernization initiatives. You will collaborate closely with cross-functional teams to ensure alignment with regulatory standards and modernization goals. The ideal candidate will have strong experience with FDA regulatory frameworks, hands-on expertise in eCTD/dossier preparation, and familiarity with regulatory information management systems such as Veeva RIM. Excellent analytical, communication, and stakeholder engagement skills are essential for success in this position.
Responsibilities:
- Conduct current state assessments of regulatory affairs processes and workflows with key stakeholders.
- Develop detailed process flow documentation and identify gaps or inefficiencies.
- Analyze opportunity areas and provide recommendations for modernization initiatives.
- Support preparation and submission of PMTA and SE applications in compliance with FDA requirements.
- Collaborate with cross-functional teams to ensure alignment with regulatory standards and modernization goals.
Qualifications:
- Proven experience in regulatory affairs, including PMTA and SE application processes.
- Strong knowledge of FDA regulatory frameworks and compliance requirements.
- Hands-on experience with eCTD/dossier preparation and submission.
- Familiarity with Veeva RIM or similar regulatory information management systems.
- Excellent analytical, communication, and stakeholder engagement skills.
Opportunities:
- Flexible remote work environment
- Opportunity to drive modernization initiatives in regulatory affairs
- Collaborative and cross-functional team culture
- Competitive hourly compensation
Disclaimer:
Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO:
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Benefits & Perks:
Calculated Hire offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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About Us
We Do Things a Little Differently
A lot of talent delivery firms come from business beginnings; we came from the tech world. Fast-paced, cutting-edge, and ever-evolving, our roots were formed in the ability to shift at a moment’s notice, stay in touch with the newest technologies, and use them to foster growth and innovation within the talent delivery industry. After branching off from our sister company, Brooksource, we created a model that infuses tech and business strategies to stay on top of talent, in touch with businesses, and ahead of the curve.
We Get to Know You—Really Know You
Whether it’s finding our clients’ top talent or getting our consultants started on a career path with purpose, we don’t cut corners, we don’t rush, and we don’t follow a one-size-fits-all approach—because each company, each individual, is different. From coffee meetings to follow-up calls to taking you to your favorite park for a walk, we’re here to get to know who you are so we can build solutions to enhance what you do.