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

Key technologies and capabilities for this role

IND submissionsCTA submissionsRegulatory documentationAgency communicationsCRO collaborationRegulatory affairsScientific communicationProject management

Questions & Answers

Common questions about this position

What is the salary range for the Sr. Associate, Regulatory Affairs position?

The salary range is $87,000 - $114,000 USD, which may vary based on factors like geographic location, candidate experience, and skills.

What is the work arrangement or location policy for this role?

This is a hybrid position requiring three days per week onsite at the office in either Burlington, MA or Redwood City, CA.

What are the key qualifications and skills required for this position?

A Bachelor’s degree in a scientific discipline is required, preferably with an advanced degree; minimum 2 years in the pharmaceutical industry; strong interpersonal, written, and verbal skills; ability to collaborate, plan, organize, prioritize, and handle ambiguity in a fast-paced environment.

What benefits are offered for this role?

Benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

What makes a strong candidate for this Regulatory Affairs role?

Strong candidates will have an advanced degree like MS or PharmD, 2+ years in pharma, excellent communication and collaboration skills, and the ability to thrive in ambiguity and fast-paced settings with flexibility for occasional travel.

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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