Regulatory Affairs Specialist

Education Requirement: In order to qualify for a Regulatory Affairs Specialist GS-0601-13 position, you must possess a Bachelor's degree, or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained). In addition, to qualify for a Regulatory Affairs Specialist GS-0601 position at the GS-13 grade level, you must have: at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: (1) Leading protocol navigation activities, including coordinating scientific review, Institutional Review Board (IRB) and/or Investigational New Drug (IND) submissions, addressing stipulations, and facilitating clinical trial protocol development processes; (2) Managing a clinical trials portfolio by liaising with investigators/ study teams, regulatory agencies, and sponsors; tracking reviews of all review bodies; and maintaining accurate essential regulatory documentation; (3) Developing regulatory documents such as protocols, consents, and associated components in accordance with federal regulatory requirements; (4) Providing regulatory expertise by analyzing complex issues, preparing safety, annual, and/or progress reports, and recommending strategies to ensure compliance and expedite review processes. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. Do not copy and paste the duties or specialized experience from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12967006 If you are an experienced Regulatory Affairs Specialist and you want to play a significant role in a dynamic organization, then consider joining the National Institutes of Health!

Position Details

• Job Title: Regulatory Affairs Specialist
• Company / Organisation: National Institutes of Health
• Location: Montgomery County, Maryland
• Employment Type: Full-time
• Field / Industry: Healthcare
• Work Arrangement: On-site or hybrid - Montgomery County, Maryland

About This Opportunity

This full-time opportunity at National Institutes of Health is an excellent opening for experienced professionals in the field of healthcare and medicine. The role is structured around an on-site or hybrid environment based in Montgomery County, Maryland and is designed for candidates who are ready to make a meaningful contribution from the moment they join.

Based in Montgomery County, Maryland, this role offers the opportunity to collaborate closely with a local team in a structured professional environment. Candidates currently based in the area or open to relocation are strongly encouraged to apply.

Whether you are an established practitioner in healthcare and medicine or a highly skilled professional looking for your next challenge, this Regulatory Affairs Specialist role offers the platform to apply your expertise in a real-world, results-oriented environment. National Institutes of Health is looking for a candidate who can hit the ground running and add genuine value to the team.

Who Should Apply

This role is ideal for candidates who have a solid background in healthcare and medicine and a demonstrable track record of delivering high-quality results. You should possess clinical competence, compassion, precision, and a commitment to patient safety and best-practice care. Experience working with electronic health record (EHR) systems, diagnostic tools, and clinical management platforms will be an advantage, though a commitment to continuous learning and professional development is equally valued.

Beyond technical or domain expertise, National Institutes of Health is looking for someone who communicates clearly, collaborates effectively with colleagues and stakeholders, and takes ownership of their work from start to finish. If you thrive in a professional environment and are passionate about the opportunity to improve patient outcomes and contribute to a healthier community, we encourage you to apply.

Key Competencies for This Role

Successful candidates for the Regulatory Affairs Specialist position at National Institutes of Health will typically demonstrate the following core competencies:

• Domain expertise - a strong foundation of knowledge and hands-on experience in healthcare and medicine
• Problem-solving ability - the capacity to identify challenges, think critically, and implement practical solutions efficiently
• Communication skills - clear and professional communication with colleagues, stakeholders, and partners at all levels
• Self-management - strong time management and the ability to prioritise a varied workload while meeting deadlines
• Team collaboration - a collaborative and supportive approach to working alongside colleagues across departments or locations
• Adaptability - the ability to respond positively to change and thrive in a dynamic, evolving work environment

How to Apply

To apply for this Regulatory Affairs Specialist position at National Institutes of Health, click the "Apply Now" button on this page. You will be taken directly to the official application page where you can complete and submit your application.

Before applying, please ensure that your CV or résumé is fully up to date and clearly highlights your experience and accomplishments in healthcare and medicine. If a cover letter is included or requested, tailor it specifically to this role and explain how your background, skills, and goals align with what National Institutes of Health is looking for in a Regulatory Affairs Specialist.

All applications for this role are processed directly by National Institutes of Health. Career Nest facilitates the job discovery process and does not pre-screen or forward applications on behalf of employers. There are no fees for job seekers at any stage of the application process.

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