[Remote] Manager, Regulatory Clinical Applications at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Autoimmune DiseasesIndustries

Requirements

Bachelor’s degree in life sciences or related field required; advanced degree preferred
5+ years of experience in clinical trial startup and regulatory affairs within the pharmaceutical or biotech industry
Familiarity with CRO operations and global regulatory requirements for clinical trial applications
Experience supporting global interventional clinical studies and managing CTA submissions
Strong organizational skills with the ability to manage multiple priorities and meet deadlines
Knowledge of GxP, ICH guidelines, and health authority regulations
Effective communication and interpersonal skills; ability to work collaboratively across teams
Detail-oriented with strong analytical and problem-solving capabilities
Proficiency in project management

Responsibilities

Support the Director in coordinating and implementing study startup activities in collaboration with CROs and internal study teams
Assist in identifying country-specific regulatory and ethics committee requirements to facilitate timely CTA approvals
Review and prepare submission packages for Regulatory Authorities and IRB/IEC for completeness and accuracy
Ensure required Quality documentation (e.g., QP declaration, GMP Certification) is available for drug release
Track and coordinate responses to Regulatory and IRB/IEC queries and deficiency letters with subject matter experts
Monitor and report on CTA status updates and study startup progress across assigned projects
Maintain internal regulatory files and ensure documentation is complete and accessible
Support the review and maintenance of the Trial Master File for regulatory and ethics committee documentation
Update global clinical trial registries (e.g., ClinicalTrials.gov) as required
Participate in Study Management Team meetings to represent regulatory/study startup perspectives
Assist in gathering and sharing regulatory intelligence related to study startup
Contribute to the development and maintenance of SOPs and process improvement initiatives
Support strategic planning and risk mitigation efforts related to study startup activities
Travel up to 10% for team meetings and company events

Skills

Key technologies and capabilities for this role

Clinical Trial ApplicationsCTARegulatory AffairsStudy StartupCRO ManagementGlobal Regulatory Submissions

Questions & Answers

Common questions about this position

Is remote work allowed for this position?

Yes, the company is open to you working remotely in the United States.

What experience is required for this role?

You must have experience with clinical trial applications to be successful in this role.

What is the salary range for this position?

This information is not specified in the job description.

What is the company culture like?

The company is building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.

Who does this role report to?

The role reports to the Director of Regulatory Clinical Applications Strategy.

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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