Regulatory Affairs CMC Specialist

Location
Gaithersburg, MD, United States
Posted
Jun 09, 2021
Ref
2020-4406
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Overview

We are currently searching for a Regulatory Affairs CMC 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, Maryland.

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). Interacts collaboratively with the Center's Office of Regulatory Sciences and Project Management groups.
  • Serve as subject matter expert for the Program's process development staff for raw material sourcing and product testing strategies
  • Interact with the Center's pilot plant manufacturing, regulatory and quality assurance staff. Reviews and provides comments, recommendations, and strategy 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.


Requirements

  • Bachelor's degree in life science from an accredited college or university. M.S. preferred.
  • Minimum of eight (8) years progressively responsible experience in Regulatory Affairs.
  • Must have at least five (5) years of experience working with biologics/large molecules CMC preparation in the US.
  • Must have direct experience assembling Regulatory applications in eCTD format.
  • Must have demonstrated strong understanding of the U.S. Regulatory requirements.
  • Must have expertise in MS Office and SharePoint.


#LI-DD1

#LI-SK1

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 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.