Full-Time

Regulatory Associate

Posted on 9/24/2025

Altasciences

Altasciences

1,001-5,000 employees

Integrated CRO for early-phase drug development

No salary listed

Overland Park, KS, USA

In Person

Category
Legal & Compliance (1)
Required Skills
Customer Service
Requirements
  • High School Diploma or GED required
  • Good Communication (French and English for Montreal location)
  • Customer service focused, able to work in fast-paced environment.
Responsibilities
  • Archival of clinical trial source documents.
  • May process and track existing and new investigator certifications and/or licenses in order for them to participate on research studies.
  • May create and maintain Delegation of Authority logs and all protocol specific training documentation for all studies.
  • May facilitate the execution of required regulatory documents, such as obtaining signatures.
  • May maintain internal electronic databases and paper logs used to track study documents.
  • May set-up and/or maintain paper-based and electronic study files.
  • Ensure the confidentiality of clinical trial participants and sponsors is respected.
  • Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
Desired Qualifications
  • College degree and related work experience preferred.

Altasciences provides an integrated CRO that handles the full early‑phase drug development path, from preclinical testing through clinical proof of concept and into manufacturing. Its approach combines discovery support, safety testing, clinical trial execution, and in‑house manufacturing to run programs under one roof. This contrasts with competitors that require pharma and biotech clients to source services from multiple vendors, adding complexity and risk; Altasciences streamlines the process by coordinating all steps. The company aims to help innovator drug programs move quickly and efficiently, delivering integrated data to de‑risk decisions and speed progression to later stages.

Company Size

1,001-5,000

Company Stage

Early VC

Total Funding

$6.7M

Headquarters

Laval, Canada

Founded

1976

Simplify Jobs

Simplify's Take

What believers are saying

  • Biotech/pharma consolidation demand for single-vendor early-phase development solutions increases.
  • 3D tissue technology adoption reduces animal testing costs and accelerates regulatory approval timelines.
  • Geographic footprint and participant database enable rapid enrollment for mid-size biopharma sponsors.

What critics are saying

  • Novo Holdings divesting Altasciences signals poor financial performance and operational cutbacks.
  • Charles River aggressive pricing on integrated packages captures 20% mid-size biopharma contracts.
  • AI-driven preclinical platforms from Insilico Medicine displace traditional animal safety pharmacology testing.

What makes Altasciences unique

  • Integrated CRO/CDMO spanning preclinical safety testing through Phase IV bioanalysis and manufacturing.
  • 9 North American facilities with 500,000+ participant database conducting 285+ trials annually.
  • VoxCell partnership integrates 3D tissue technology for human-relevant preclinical testing.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Paid Vacation

Paid Sick Leave

Paid Holidays

Employee Assistance & Telehealth Programs

Remote Work Options

Company News

GlobeNewswire
Mar 16th, 2026
Outlook Therapeutics Announces New $18.4 Million Non-Convertible Note Financing and Amendment to Existing Convertible Note

ISELIN, N.J., March 16, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard...

Business Wire
Aug 20th, 2025
Altasciences Receives EcoVadis Gold Medal for Environmental, Social, and Governance (ESG) Efforts

EcoVadis, the world's most trusted provider of business sustainability ratings, has collaborated closely with Altasciences to enhance its environmental, social, and governance (ESG) initiatives, underscoring the company's commitment to a sustainable future and a reduced environmental footprint.

Yahoo Finance
Jul 31st, 2025
Altasciences and VoxCell BioInnovation Announce Strategic Collaboration to Advance Preclinical Drug Development

This partnership combines Altasciences' comprehensive early-phase drug development capabilities with VoxCell's cutting-edge 3D tissue technology to offer a more predictive and human-relevant preclinical testing environment.

Postmedia Network
Mar 28th, 2025
Altasciences Receives 2025 CDMO Leadership Award in Small Molecule Dosage Form Category

For 14 years, Outsourced Pharma's CDMO Leadership Awards have recognized the top-performing contract development and manufacturing organizations based on comprehensive industry research, and feedback from sponsors.

BioSpace
May 29th, 2024
Altasciences Receives 2024 CRO Leadership Award for Capabilities

Altasciences receives 2024 CRO Leadership Award for Capabilities.

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