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Alston

FDA Technical Consultant

Washington, DC · On-site +1

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA practice out of the Washington, D.C. Office. Qualified candidates will have at least 5 years' experience ...

Alston & Bird's

FDA Technical Consultant

Washington, DC · On-site

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA practice out of the Washington, D.C. Office. Qualified candidates will have at least 5 years' experience ...

Eliquent Life Sciences, Inc

Consultant 1

Montrose, CA · On-site

Provide support during audits and inspections to ensure systems meet regulatory expectations (FDA ... Consultant I (Entry-Level / Junior) * Experience: 0-3 years CSV or validation experience in GMP ...

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How much do fda consultant jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for fda consultant in the United States is $41.55, according to ZipRecruiter salary data. Most workers in this role earn between $29.33 and $49.52 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of an FDA consultant?

As an FDA Consultant, your days often involve preparing and reviewing regulatory submissions, advising clients on compliance strategies, and staying up-to-date with evolving FDA requirements. You'll work closely with clients in pharmaceutical, medical device, or biotech companies to interpret regulations, conduct gap analyses, and support product development from early stages through post-market compliance. Collaboration with cross-functional teams, such as research, quality assurance, and legal, is common to ensure all processes and documentation meet FDA standards. The work environment is typically a mix of independent analysis and interactive client meetings, offering a balance between technical expertise and strategic consulting.

What are the key skills and qualifications needed to thrive in the FDA consultant position, and why are they important?

To thrive as an FDA Consultant, you need in-depth knowledge of FDA regulations and guidelines, regulatory submission processes, and a relevant science or healthcare background. Familiarity with regulatory databases, document management systems, and certifications like RAC (Regulatory Affairs Certification) are highly valued in this field. Strong analytical skills, attention to detail, and effective communication are key soft skills for advising clients and coordinating with multidisciplinary teams. These skills are essential for ensuring clients achieve compliance, avoid costly delays, and succeed in the highly regulated life sciences industry.

What is an FDA consultant?

An FDA Consultant helps businesses navigate FDA regulations to ensure compliance with federal laws related to drugs, medical devices, food, and other regulated products. They provide expert guidance on submissions, approvals, inspections, and regulatory strategies. Their role is crucial for companies seeking to bring products to market while meeting all legal requirements.

How to become a Fda consultant?

To become an FDA consultant, professionals typically need a background in life sciences, healthcare, or regulatory affairs, along with experience in FDA regulations and compliance. Earning certifications such as RAC (Regulatory Affairs Certification) can enhance credibility, and understanding FDA guidelines for pharmaceuticals, medical devices, or food products is essential. Building industry experience and networking within regulatory communities are also important steps.
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Infographic showing various Fda Consultant job openings in the United States as of August 2026, with employment types broken down into 87% Full Time, 7% Part Time, and 6% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $86,430 per year, or $41.6 per hour.

FDA Technical Consultant

Alston

Washington, DC • On-site, Remote

Full-time

Re-posted 9 days ago

Job description

THE FIRM

As a leading international law firm, we are dedicated to excellence through impactful communication, collaboration, and community involvement. Our company culture has earned us one of the "100 Best Companies to Work For" for 27 consecutive years. This honor, along with many others, highlights our commitment to innovation and professional development. At Alston & Bird LLP, our foundation is made of trust, reliability, and compassion.

JOB DESCRIPTION

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA practice out of the Washington, D.C. Office. Qualified candidates will have at least 5 years' experience as an FDA investigator or a senior role in global quality, to assist our FDA team in responding to FDA inspections at pharmaceutical and medical device manufacturing sites. This role offers flexibility to work hybrid or a fully remote arrangement. Candidates should be self-starters, highly organized, and team players. Extended hours and regular domestic and international travel are often needed to meet client deadlines.

Key Responsibilities

  • Assist attorneys in supporting manufacturing clients on issues related to Current Good Manufacturing Processes (CGMP) compliance

  • Prepare clients for inspections, provide inspection support (remote and on-site)

  • Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other enforcement actions

  • Extensive knowledge and experience related to quality systems, investigations, Corrective & Preventative Actions (CAPAs), contamination control, cleaning validation, and data integrity are essential for this role

  • Collaborate with cross-functional teams at the Firm and at the client including legal, regulatory, quality, manufacturing, and executive leadership teams

  • Draft memos regarding the status of projects

  • Maintain current and accurate daily time record

  • Perform special projects as assigned

SKILLS NEEDED TO BE SUCCESSFUL

  • Regular travel within the United States and Internationally. Regular travel 1-2 weeks a month with flexibility for more.

  • Ability to organize and prioritize numerous tasks and complete them under time constraints.

  • Interpersonal skills necessary in order to communicate and follow instructions effectively from a diverse group of clients, attorneys and staff and provide information with ordinary courtesy and tact.

  • Work typically requires more than 40 hours per week to perform the essential duties of the position; may require irregular hours.

  • Ability to travel to private and public buildings, domestically and internationally, via private or public conveyance to assist attorney in attending to client needs on legal matters.

EDUCATION & EXPERIENCE

  • Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related field.

  • FDA experience required.

  • Minimum of 5 years as an FDA investigator or compliance officer, or industry senior position in global quality assurance.

  • In-depth knowledge of quality systems, regulatory requirements (21 CFR Parts 210, 211 and related guidance), quality management systems (QMS), and ISO standards.

  • Strong analytical skills with a focus on root cause analysis and problem-solving.

  • Excellent written and verbal communication skills, enabling effective interaction with various stakeholders.

  • Proficient in using quality management systems and documentation tools.

  • Ability to provide exceptional client service and manage multiple engagements in a fast-paced environment.

  • Willingness to frequently travel to international and domestic client sites to support inspections, audit, and remediation activities.

The salary range for this position in Washington D.C. is $200,000-$250,000 and represents the firm's good faith minimum and maximum range for this role at the time of posting. The actual salary offered will be dependent on various factors, including but not limited to, the candidate's experience, education, relevant certifications, geographic location, market demands, and specific business needs. Generally, candidates are considered for the higher end of the salary range when they bring the requisite level of experience and expertise to the role.

EQUAL OPPORTUNITY EMPLOYER

Alston & Bird LLP is an Equal Opportunity Employer does not discriminate on the bases of any status protected under federal, state, or local law. Applicants will be considered regardless of their sex, race, age, religion, color, national origin, ancestry, physical disability, mental disability, medical condition (associated with cancer, a history of cancer, or genetic characteristics), HIV/AIDS status, genetic information, marital status, sexual orientation, gender, gender identity, gender expression, military and veteran status, or other protected category under the law on the basis of race, color, religion, sex, age, sexual orientation, gender identity and/or expression, national origin, veteran status or disability in relation to our recruiting, hiring, and promoting practices.

The statements contained in this position description are not necessarily all-inclusive, additional duties and responsibilities may be assigned, and requirements may vary from time to time.

Professional business references and a background screening will be required for all final applicants selected for a position.

If you need assistance or an accommodation due to a disability you may contactdonavan.mclean@alston.com.

Alston & Bird is not currently accepting resumes from agencies for this position. If you are a recruiter, search firm, or employment agency, you will not be compensated in any way for your referral of a candidate even if Alston & Bird hires the candidate.

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