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Regulatory Affairs Scientist

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Bethesda, Maryland
Start date
Jan 22, 2022

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

We are currently searching for a Regulatory Affairs Scientist 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 Bethesda, MD.

 

Duties & Responsibilities
  • Participate in monthly calls on the Malaria L9LS study to review the progress.
  • Review the protocol prior to scientific review of the Malaria L9LS study.
  • Develop regulatory strategies appropriate for manufacturing clinical products for Phase I, II, and III trials, e.g., planning, reviewing, and overseeing manufacturing methods, toxicology protocols, and preclinical packages.
  • Make recommendations regarding alternative serotypes for adenoviral vector vaccine candidates, and assessments of direct viral load and viral immunology studies in concert with researchers.
  • Responsible for chemistry, manufacturing, and controls (CMC) of all investigational new drug (IND) applications for vaccines and related products and oversee the planning, preparation, and review of IND materials to ensure compliance with FDA guidelines and the Code of Federal Regulations (CFR).
  • Provide expertise for testing and characterizing strategies for cell substrates, vaccine constructs, and vaccine formulation.
  • Responsible for assembling all CMC IND packages for integration and submission to regulatory authorities by other intramural or extramural agencies.

 

 

Requirements
  • Bachelor’s degree with seven (7) to ten (10) years of related experience OR Master’s degree with five (5) to seven (7) years of related experience is required.
  • Project management skills and ability to synthesize project workloads is required
  • Experience developing regulatory strategies for clinical trials useful.
  • Expertise in testing and characterizing cell substrates, vaccine constructs and vaccine formulation.
  • Experience working with IND submissions and adhering to Federal Drug Administration (FDA) regulations and compliance laws.

#LI-EJ1

 

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

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

 

 

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