Regulatory Affairs Manager V

Goldbelt, Inc.•Frederick, MD

About The Position

The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.

Requirements

Bachelor's or Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
Experience in developing and implementing regulatory strategies and overseeing regulatory filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.).
Experience with providing critical review of documentation supporting regulatory applications.
Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e.g. FDA regulations, ICH guidelines).
Experience with medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity.
Mastery of FDA and other relevant regulatory authorities' requirements for clinical study development and implementation and marketing and post-marketing. Contractors shall have experience applying this expert knowledge to products made available through normal approval processes or emergency use mechanisms.
Clearance: Secret

Nice To Haves

Certification in Regulatory Affairs or other certification relevant to medical product development and/or auditing is desired and will be at no cost to the Government.

Responsibilities

Serve as a liaison between the AJPEO MRAS regulatory office and product leads to ensure DoD funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidance.
Serve as a subject matter expert in regulatory affairs at the working group-level to inform innovative regulatory approaches to develop MCMs against emerging threats.
Elevate critical programmatic and project level regulatory challenges to the AJPEO MRAS regulatory office on critical programmatic and project level regulatory challenges.
Provide training and advisement to DOD staff on regulations, authoring regulatory documents, and interactions with regulatory authorities
Provide input to Sponsors' regulatory documents for submission to FDA or other National Regulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National Regulatory Authority requirements and with the eCTD submission format, as applicable.
Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system.
Contribute to the modification, development and implementation of internal policies and procedures.
Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participate in regulatory audits/inspections as required.
Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies
Provide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.
Create and/or review acquisition and contract documents ((e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.
Travel for presentations and seminars, and to observe and provide regulatory assessments of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.).
The contractor shall receive debriefs at the Secret level on Biannual Threat Briefs and be able to assist on course of action development in support of IPT's.