Bering-Alaka`ina Holdings, LLC is looking for has a potential need for a
Regulatory Affairs Support Subject Matter Expert to provide support for our government customer in
Frederick, MD at Fort Detrick Army Base.DESCRIPTION OF RESPONSIBILITIES:- Provide specialized guidance and support and serve as a technical resource, offering in-depth expertise on relevant regulatory requirements, strategies, and processes to ensure successful product development, submission, and lifecycle management.
- Provide expert advice and guidance on drugs, biologics, and devices and their application to the development of military-relevant medical solutions; develop and review regulatory strategies, including submission planning, dossier preparation, and communication with regulatory agencies; evaluate and interpret regulatory guidelines, directives, and policies, and assess their impact on developmental programs; prepare and review regulatory submissions, including but not limited to INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting submission packages and minutes, audit and inspection reports.
- Support regulatory agency interactions, including preparation for meetings, communication with Sponsors, responses to queries, and management of commitments.
- Conduct gap analyses of existing processes and documentation against current regulatory requirements.
- Provide training and mentorship to team members on regulatory requirements and best practices; stay current on changes to relevant regulations, guidelines, and industry standards and communicate these changes to the team.
- Collaborate with cross-functional teams, including R&D, manufacturing, clinical, and marketing, to ensure regulatory compliance throughout the product lifecycle.
- Proactively communicate with and advise product managers, IPTs, and leadership on regulatory risks, opportunities, and issues.
- Collaborate as necessary to identify regulatory affairs (RA) strategies to optimize product development across the portfolio.
- Review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data; facilitate an understanding of the requirements for compliance with all applicable FDA regulations.
- Understand and plan for future clinical trials and other pre-clinical trial milestones; coordinate and assist in the review of all pre-clinical trial documents; and keep current files of all information disseminated by the FDA and other policy bodies that affect products and will interpret, synthesize, and incorporate the new information into the organization.
- Assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g. tasks, documents, meetings,) to include estimated timelines required to support the product development of medical devices, drugs, biologics, blood and blood products and or other medical solutions.
- Other duties as assigned by Supervisor.
REQUIRED DEGREE/EDUCATION/CERTIFICATION:- Must hold minimum of Bachelor's degree.
REQUIRED SKILLS AND EXPERIENCE:- Must have minimum of six to eight (6-8) years' of relevant experience.
- Must have expertise on relevant regulatory requirements, strategies, and processes regarding product development, submission, and lifecycle management.
- Must have expertise on drugs, biologics, and devices and their application to the development of military-relevant medical solutions.
- Must have a strong understanding of the product development lifecycle and regulatory requirements at each stage.
- Must have an in depth knowledge of development of drugs, biologics, blood and blood products, medical devices, and other medical solutions.
- Must have strong problem-solving and analytical skills.
- Must be able to work independently and as part of a team.
REQUIRED CITIZENSHIP AND CLEARANCE:- Must be a U.S. Citizen, born or naturalized; for the purposes of this work Visa and GreenCard holders do not qualify and will not be considered.
- Must be able to pass a Tier 1 Background Investigation for position of Public Trust.
This posting is a pooling requisition only for a position(s) associated with a proposal for a Government contract. A hiring action will not be made from this requisition, and salary information is not available.
Bering-Alaka`ina Holdings, LLC is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.
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