Returning Candidate? Log back in! Regulatory Affairs Manager V Job Locations US-Remote-Remote Hire ID 2024-14565 Category Medical and Defense Services Position Type Regular Full-Time Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices. 

 

Summary:

Goldbelt Apex LLC is seeking a qualified Regulatory Affairs Manager V to support our Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance. You must be a U.S. citizen.

Responsibilities

Essential Job Functions:

Provide regulatory advice, management, and oversight of total lifecycle management to cross-functional groups to inform early product development through interim fielding (emergency use regulatory mechanisms) to approval, clearance, or licensure and throughout post-marketing as appropriate.Lead the development and review of regulatory documents for submission to FDA or other National Regulatory Authorities (NRAs) and coordinate/prepare and maintain FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) by US FDA or other National Regulatory Authority requirements and with the eCTD submission format, as applicable.Draft, manage, maintain and retain regulatory and quality 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 the in accordance with approved business rules in the assigned electronic document management system (such as EDMS). Contribute to the modification, development, and implementation of internal policies and procedures for regulatory affairs (such as SOPs)Develop and implement regulatory strategies for launching new products and maintaining existing products and provide review, comments, and approval of all product claims for technical accuracy and regulatory compliance. Represent the regulatory team, provide guidance and oversight to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, present, orally and in writing, the outcome of these efforts promptly and participate in regulatory audits/inspections as required.Plan, prepare, and execute for meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies and build rapport with regulators to the best position for a positive outcomeProvide advice and aid in implementing quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards to support advanced development activities. Conducts quality audits and oversight, as assigned for non-clinical, clinical, and manufacturing activities in compliance with relevant laws, regulations, and policies. Create and 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, 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 oversee supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.). Qualifications

Necessary Skills and Knowledge:

Strong communication skills, effectively communicating ideas, requirements, and scientific knowledge; and self-starting.

Minimum Qualifications:

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.Tradeoff Requirement: Bachelor’s or Master’s degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.Experience 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 biologics and/or devices, and combination medical product laws, regulations and policies (e.g. FDA regulations, ICH guidelines). Contractor shall have the capability to interpret and apply their regulatory expertise to the Joint Program Executive Office for Chemical, Biological, Radiological, Nuclear Defense (CBRND) and Defense Threat Reduction Agency Joint Science and Technology Office (DTRA-JSTO).Possess a mastery of current commercial advanced pharmaceutical development and associated intellectual property management best practices and maintain currency thereof. Experience with medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity, and other non-clinical and clinical research and development standards, requirements, and considerations. Mastery of cGxPs (cGLP, cGMP, cGCP, etc.) and expert knowledge in regulatory affairs related to pharmaceutical development and experience applying this specialist knowledge to complex technical problems with minimal supervision. A tradeoff requirement… possess expertise in Quality Assurance/Compliance and Auditing for medical product development and marketing. Mastery of FDA and other relevant regulatory authorities’ requirements for clinical study development, implementation, marketing, and post-marketing. Experience applying this expert knowledge to available products through normal approval processes or emergency use mechanisms.Only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Preferred Qualifications:

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

The salary for this position is a minimum of $165,000 per year.

 

Pay and Benefits
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

 

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