Regulatory Affairs Specialist

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Job description

We are currently searching for a Regulatory Affairs Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Gaithersburg, MD.

Duties & Responsibilities

• Responsible for chemistry, manufacturing and controls (CMC) information of all investigational new drug (IND) applications for vaccines, monoclonal antibodies, and related biological products.
• Assist regulatory program managers with CMC-relevant responses to comments from regulatory authorities.
• Oversee planning, preparation and review of Module 3 sections in Common Technical Document (CTD) format for submission to regulatory authorities.
• Ensure documentation follows FDA guidelines and Code of Federal Regulations (CFR).
• Interact collaboratively with Office of Regulatory Sciences and Project Management groups.
• Serve as a subject matter expert for process development staff, for raw material sourcing and product testing strategies.
• Interact with the pilot plant manufacturing, regulatory and quality assurance staff.
• Review and provide comments, recommendations, and strategies on product specifications, stability protocols, comparability protocols and reports, investigator brochures and other related CMC documents during product development of biological products for early phase clinical trials.

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Requirements

• Bachelor's Degree in life sciences or a related field from an accredited university. M.S. degree highly preferred.
• Minimum of six (6) years of related experience, progressively responsible experience in Regulatory Affairs.
• Minimum of five (5) years working experience with biologics or vaccines CMC preparation in the US.
• Direct experience assembling Regulatory applications in eCTD format.
• Demonstrated strong understanding of the U.S. Regulatory requirements.
• Excellent written and verbal English communication skills.
• Demonstrated excellent organizational skills.
• Expertise in MS Office and SharePoint

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• Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get…

• Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
• Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
• Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
• Discovery! With our tuition assistance and training programs, we support your career advancement.
• Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
• Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
• Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
• A Voice! A unique culture where you can influence decisions and have your voice heard.

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.

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