Regulatory Affairs Associate

Location
Gaithersburg, MD, US
Posted
Mar 13, 2021
Ref
2021-9659
Hotbed
BioCapital
Required Education
Other
Position Type
Full time
Overview

We are currently searching for a Regulatory Affairs Associate 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

  • Archive records and entry of regulatory activities within the various data management systems for Investigational New Drug (IND) applications and other regulatory submissions.
  • Work closely with program members, to coordinate and ensure the successful completion of the regulatory activities within the agreed timelines, and in compliance with applicable regulations.
  • Provide regulatory operations support to the regulatory office through document control management and quality assurance.
  • Work on special projects in order to assist staff in meeting program timelines.
  • Interact with other components of the program, involved in product development; obtain, assist writing and review of non-clinical and CMC data.
  • Assist personnel with developing templates and letters for regulatory submissions to the FDA and sites.
  • Verify the integrity of sponsor files, ensuring the availability of clinical and non-clinical materials, review the required documentation in the document control system according to the current practices and applicable guidelines, and check for consistency with the contents of sponsor files.
  • Assist with developing and managing tracking databases to support regulatory filings and ensure Sponsor's commitments are met.
  • Develop and implement SOPs and work instructions for processes
  • Complete quality review of internal documents and eCTD submissions as needed.


Requirements

  • Bachelor's degree in biology, biochemistry, or other life science is required.
  • Minimum of one (1) to two (2) years of experience in Regulatory Affairs.
  • Background in document management, and/or archiving systems is desirable.
  • Working knowledge of and aptitude for activities related to quality assurance.
  • Strong verbal and written communication skills and ability to work in a group setting and collaborate with other functional area are required.
  • Advanced knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems.
  • Knowledge of Title 21 Code of Federal Regulations (CFR) (GCPs, GLPs GMPs) to ensure FDA regulatory compliance.

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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.