Posted today
Job id: a1Wcv000000BS0zEAG
Regulatory Affairs Analyst
McLean, Virginia
Hybrid
25
Contract
Calculated Hire
-$80/hr
-k
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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:
Eight Eleven Group 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
Your need for talent is our reason for being. This driving mission has been at our core from the onset. When we started in 2000 at 811 Broad Ripple Avenue, we were a team of forward-thinking entrepreneurs determined to find a better way to connect the best and brightest talent with companies looking for future leaders. We still believe in this philosophy. Throughout the years, our passion, credibility, and grit have been the foundation and prowess of what is now Eight Eleven. Though our focus areas have continued to mindfully evolve, our unyielding commitment to relationships and our customers’ needs remain consistent and firmly rooted in our core values.