Sr. Associate, Regulatory Affairs at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in a scientific discipline (required); relevant advanced degree (e.g., MS, PharmD) preferred; certification a plus
Minimum of 2 years in the pharmaceutical industry
Strong interpersonal, written, and verbal skills
Ability to understand and communicate scientific/clinical information
Ability to collaborate with team members to tackle problems and develop a course of action
Strong planning and organizing skills
Ability to prioritize and balance multiple activities
Ability to deal with ambiguity and fast-paced environment
Flexibility to react rapidly to changing situations/environment
Willingness to travel for occasional in-person team meetings
Hybrid position requiring three days per week onsite at Burlington, MA or Redwood City, CA

Responsibilities

Assist Regulatory Lead to support local regulatory activities (e.g., IND/CTA submissions and agency meetings)
Provide and maintain IND/CTA documentation support in collaboration with Regulatory Lead (e.g., draft and prepare forms and cover letters, liaise with and transfer documents for submissions to/from the publishing vendor or CRO)
Create and maintain product regulatory information and history documents (e.g., maintain correspondence logs)
Appropriately archive regulatory documents and agency communications
Collaborate with CROs/partners to support clinical study activities
Complete regulatory forms to support agency communications
Provide regulatory support through cross-functional interactions in project meetings
Support the development and execution of project goals
Monitor the development of new regulatory requirements or guidance documents and support Regulatory Lead to advise product teams of the impact on the business or development programs

Skills

IND submissions

CTA submissions

Regulatory documentation

Agency communications

CRO collaboration

Regulatory affairs

Scientific communication

Project management

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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