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Live In Fda Scientist Jobs in Boston, MA (NOW HIRING)

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

$259K - $317K/yr

By combining scientific innovation with a collaborative, purpose-driven culture, we strive to ... Deep expertise in FDA regulations and guidance (21 CFR, ICH guidelines), with strong working ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

$259K - $317K/yr

By combining scientific innovation with a collaborative, purpose-driven culture, we strive to ... Deep expertise in FDA regulations and guidance (21 CFR, ICH guidelines), with strong working ...

Nova Biomedical Corporation

Scientist I

Waltham, MA · On-site

$65K - $75K/yr

The Scientist I applies scientific principles to solve complex technical problems and support ... FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and ...

Nova Biomedical

Scientist I

Waltham, MA · Hybrid

$65K - $75K/yr

The Scientist I applies scientific principles to solve complex technical problems and support ... FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and ...

Amgen, Inc.

Analytical Sr Scientist

Cambridge, MA · On-site

$100K - $136K/yr

Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical ... live the Amgen values to continue advancing science to serve patients. Together, we compete in the ...

Orum Therapeutics

Bioanalytical Scientist

Lexington, MA · On-site

$39.50 - $49.75/hr

As a key scientific lead, you will orchestrate the bioanalytical lifecycle - from internal method ... in alignment with GLP/GCP standards and current FDA guidance. * Act as the BioA/PK subject matter ...

Orum Therapeutics

Bioanalytical Scientist

Lexington, MA · On-site

$150 - $180/day

As a key scientific lead, you will orchestrate the bioanalytical lifecycle - from internal method ... in alignment with GLP/GCP standards and current FDA guidance. * Act as the BioA/PK subject matter ...

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All JobsLive In Fda Scientist JobsLive In Fda Scientist Jobs in Boston, MA

Live In Fda Scientist information

What is a live in FDA scientist?

A Live In FDA Scientist typically refers to a regulatory scientist who works for the U.S. Food and Drug Administration (FDA) and may be involved in on-site or continuous monitoring of studies, often in clinical or laboratory settings. Their role includes evaluating scientific data, ensuring compliance with federal regulations, and overseeing the safety and efficacy of products such as drugs, biologics, or medical devices. Live-in positions might be required for research facilities needing 24/7 oversight, although such roles are rare and specialized. These scientists play a crucial role in public health by supporting the FDA’s mission to protect consumers.

What are some unique challenges faced by a live in FDA scientist, and how can they be managed?

A Live-In FDA Scientist often works in environments such as research facilities or clinical trial sites where on-site presence is essential. This setup can present challenges like maintaining work-life balance, adapting to extended hours, and managing confidentiality due to the sensitive nature of ongoing research. Successful candidates typically develop strong time management skills, set clear personal boundaries, and foster open communication with team members to ensure both professional responsibilities and personal well-being are balanced. Collaboration with multidisciplinary teams is frequent, and adaptability is key to thriving in this dynamic role.

What are the key skills and qualifications needed to thrive as a live in FDA scientist, and why are they important?

To thrive as an FDA Scientist, you need a strong background in life sciences or chemistry, typically with an advanced degree (MS or PhD) and experience in research or regulatory affairs. Familiarity with laboratory instrumentation, data analysis software, and FDA regulatory systems is essential, and certifications like RAC (Regulatory Affairs Certification) can be advantageous. Attention to detail, critical thinking, and excellent communication skills help you interpret data accurately and collaborate effectively with multidisciplinary teams. These skills ensure scientific integrity, regulatory compliance, and the advancement of public health through safe and effective products.

What is the difference between Live In Fda Scientist vs Fda Reviewer?

AspectLive In Fda ScientistFda Reviewer
Required credentialsBachelor's or Master's in Life Sciences, relevant experienceSimilar credentials, often with advanced degrees
Work environmentOn-site, often in government or research facilitiesOffice-based, reviewing submissions at FDA headquarters or regional offices
Employer and industry usageFederal government, regulatory scienceFederal government, regulatory review
Common search intentJob duties, qualifications, work conditionsComparison of roles, responsibilities, career path

The Live In Fda Scientist and Fda Reviewer roles both require scientific expertise and federal employment credentials. While the Live In Fda Scientist often involves conducting research and scientific analysis on-site, the Fda Reviewer primarily focuses on evaluating regulatory submissions and documentation. Both roles are integral to FDA operations, but they differ in daily tasks and work environment, with the scientist more research-oriented and the reviewer more review-focused.

How much do live in FDA scientists make?

Live-in FDA scientists typically earn a salary comparable to federal scientific positions, which can range from approximately $70,000 to over $130,000 annually depending on experience, education, and location. They often receive benefits such as health insurance and retirement plans, and may work in regulated environments requiring specialized certifications.

What are the most commonly searched types of Fda Scientist jobs in Boston, MA?

The most popular types of Fda Scientist jobs in Boston, MA are:

Live In Fda Scientist jobs near you

Senior Director, Regulatory Affairs

Waltham, MA • On-site

Ardelyx
Manufacturing • 51 - 200 employees
Learn more about Ardelyxexternal

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 17 days ago

Job description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.
 
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
 
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.
 

Position Summary:

The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio. This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring full compliance with applicable regulations and guidance.

Responsibilities:

  • Develop and own global regulatory strategies for pipeline and marketed products, from early development through post-approval lifecycle management
  • Serve as the primary regulatory strategist on cross-functional development teams (CDTs), aligning regulatory planning with clinical and commercial objectives
  • Provide regulatory intelligence and proactive risk assessment to senior leadership, including Board-level briefings when appropriate
  • Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements
  • Partner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications
  • Review and provide regulatory input on protocols, IBs, CSRs, and other clinical documents to ensure alignment with regulatory strategy
  • Lead preparation and execution of IND/CTA submissions and amendments; oversee clinical hold response strategy
  • Drive BLA/NDA/MAA submission planning and execution, including authoring and reviewing Module 2 summaries and managing cross-functional submission teams
  • Oversee preparation, review, and submission of major regulatory filings (IND, BLA/NDA, MAA) and post-approval submissions (CBEs, PASs, supplements, annual reports)
  • Establish and maintain submission timelines, resource plans, and submission-readiness frameworks
  • Ensure eCTD compliance and maintain submission infrastructure in partnership with Regulatory Operations
  • Build, mentor, and retain a high-performing regulatory affairs team
  • Monitor and interpret new and evolving FDA/EMA guidances, PDUFA commitments, and international regulatory developments; assess impact on programs and communicate to leadership

Qualifications: 

  • Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience
  • Demonstrated success leading BLA, NDA, or MAA submissions from initiation through approval
  • Deep expertise in FDA regulations and guidance (21 CFR, ICH guidelines), with strong working knowledge of EMA and other major regulatory frameworks
  • Proven track record of leading Health Authority meetings and managing complex, high-stakes regulatory interactions
  • Experience in clinical regulatory strategy, including protocol design input, trial design, and endpoint negotiation with agencies
  • Strong leadership skills with experience managing and developing teams of regulatory professionals
  • RAC certification (RAPS) is a plus
  • Experience across multiple therapeutic areas or modalities (small molecule, biologics, gene therapy, combination products) desirable
  • Global regulatory experience including ex-US submissions and agency interactions desirable
  • Prior experience with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs preferred
 
The anticipated annualized base pay range for this full-time position is $259,000 - $317,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.     
 
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. 
  
Ardelyx is an equal opportunity employer.
 
We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.