Regulatory Affairs Analyst for Acute Radiation Syndrome

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Regulatory Affairs Analyst for Acute Radiation Syndrome Medical Countermeasures Development
Background
The HHS is responsible for developing and procuring medical countermeasures (MCM) against potential public health
threats, to include natural occurring epidemic threats such as influenza as well as chemical, biological, radiological and
nuclear threats. These technologies/products cross the gamut of vaccines, drugs, and devices. Through formal contract
procedures, HHS is authorized to fund pharmaceutical/biotech contractors that conduct the development and
manufacturing. HHS requires subject matter experts to assist their government staff in initiating and monitoring the
medical countermeasures development and manufacturing contracts. This technical advisory support covers the entire
range from the inception of requirements to placing FDA-approved products into the strategic national stockpile. In this
comprehensive role, HHS requires individuals with experience and understanding in FDA regulatory procedures to assist
in regulatory plans, assess regulatory risks and recommend timely solutions, assist the MCM contractors in preparing for
meetings with the FDA, and write and review documentation (clinical protocols, reports, CMC data, results, SOPs, etc).
Position Description:
The analyst position will work as an integral member of Project Coordination Teams with responsibility for establishing
regulatory requirements within the contractual solicitations. In addition the analyst will be expected to evaluate a
bidder’s regulatory pathways, assess the regulatory status and plans, and monitor the regulatory documentation, and
provide expert advice to the government. The individual will further assist in the submission of documents to the FDA,
as well as any communications/meetings request. The individual will assist the government in managing the
contractor’s regulatory strategy throughout the life of the contract, including the final FDA approval and post-approval
manufacturing stages. This individual may conduct site audits and documentation review to determine compliance and
identify any potential risks. The primary area of interest is products for acute radiation syndrome. Knowledge and
experience with the FDA Animal Rule and with Regulatory Operations is desired.
Specific Duties and Responsibilities will include, but are not limited to, the following:
1. Work with the HHS Project Team to implement Regulatory / Quality plans for assigned projects
2. Review supported company submissions, which may include INDs, Briefing Documents, Orphan Drug
Applications, and Marketing Applications, etc.
3. Review and comment on supported company’s regulatory strategy, as assigned.
4. Participate or act as regulatory representative on various cross-functional teams, as assigned.
5. Participate or lead regulatory interactions with FDA, as assigned.
6. Monitor supported company’s project timelines for FDA submission.
7. Maintain knowledge on the US competitive landscape, regulatory environment, regulations and guidances.
8. Provide Regulatory Research and Intelligence support for team as assigned.
9. Review white papers/proposals
10. Support contract initiation/negotiation efforts. Participate in contract kick-off and ongoing meetings at
supported company sites.
11. Review and evaluate supported company’s Quality Program including review of company Quality Manual,
Policies and SOPs.
12. Review and evaluate supported company documents including development plans, development study reports,
study protocols and reports for GXP Quality Compliance.
13. Perform GXP Quality Assessments.
14. Provide review and comment on Quality Agreements
15. Draft meeting minutes, trip reports, and technical assessments and recommendations on the Regualtory and
Quality aspects of BARDA-contractor interactions.
16. Evaluate supported company contract documents, including funding proposals, statements of work and reports
from a Quality and Regulatory perspective.
17. Attend and participate in industry conferences on BARDA’s behalf.
Position Requirements:
1. Minimum MA/MS (or equivalent degree) and 10+ years of relevant work experience within the Pharmaceutical
or Healthcare industries. Experience with Oncology or Hematology therapeutic areas is a plus.
2. Comprehensive understanding of the drug development process
3. Experience with the FDA Animal Rule is a plus.
4. Experience with regulatory operations with understanding of GCP and cGMP/CMC requirements.
5. Proven ability to function as a subject matter expert within an integrated product team.
6. Experience in conducting FDA discussions and submitting the full gamut of related documents to the FDA
reviewing division.
7. Experience in bringing a product through the entire development process; and experience achieving FDA
approval through the marketing and manufacturing phase is a plus
8. Excellent interpersonal and communication skills (both written and verbal)
9. Regulatory Affairs Certification preferred.
10. Experience with Products for treatment of one or more of the following conditions is desired:
Acute Radiation Syndrome including
 GI Syndrome
 Bone Marrow Syndrome
 Cardiovascular Syndrome
 Cutaneous Syndrome
Lung pneumonitis and fibrosis
Neutropenia
Beta-burn injury
Cs-137 decorporation
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