Frederick, MD Posted: 8/18/2021
We have an outstanding Contract to Hire position for a Senior Scientist to join a leading Company located in the Frederick, MD surrounding area.
The Regulatory Affairs Scientist will ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy, to include identifying and mitigating risk, and provide support to integrated project teams and working groups.
What You'll be Doing:
- Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure leadership and the sponsor’s representative are kept current on the progress of the program through periodic reports.
- Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team of any FDA-related activities and issues, and attending meetings, updating leadership and the sponsor’s representative through routine reports.
- Lead the development of a written regulatory strategy and provide to the Government. The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
- Identify and mitigate regulatory risk through a project Risk Register.
- Serve as the primary contact with the FDA; review, analyze, and respond to FDA communications and meetings by the regulatory deadline.
- Lead the development, organization, and structure of regulatory submissions and meeting minutes in EDMS
- Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions.
- Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities.
- Confirm the need for registration, based on regulation and Army policy, and provide regulatory support for data entry and quality assurance of ClinicalTrials.gov information/entries, a Web-based resource that provides information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
- Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents.
- Some travel may be required.
What You'll Need:
- Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
- 5+ years of regulatory experience: leading the development of writing regulatory strategies for FDA, communicating and responding to the Government and FDA on submissions, identifying and mitigating regulatory risk, etc.
- Must be highly organized, detail-oriented, and perform independently.
- Have excellent Microsoft Excel Spreadsheet skills.
- Excellent written and oral communication skills.
- Must be U.S. citizen and be able to obtain a TI (Public Trust).
What Would be Even Better:
Minimum Security Clearance:
TAD PGS, Inc. is a Global Fortune 500 company with worldwide revenue of over $27 billion and more than 50 decades of government contracting experience. We specialize in supporting U.S. Government Agencies and their prime vendors by delivering a full range of recruitment and workforce solutions. As part of the Adecco family, we have access to over 2.5 million active candidates supporting hundreds of locations across North America. On any given day, we have more than 70,000 professionals working at client sites across the United States.
VEVRAA Federal Contractor / Request Priority Protected Veteran Referrals / Equal Opportunity Employer / Veterans / Disabled
The Company will consider qualified applicants with arrest and conviction records.
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