Director/Senior Director, Regulatory Affairs Strategy at Abata Therapeutics

Menlo Park, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in a life sciences discipline; advanced degree preferred; Regulatory Affairs Certification (RAC) a plus
Minimum 8 years progressive pharmaceutical Regulatory Affairs experience

Responsibilities

Serve as Regulatory Affairs lead on multidisciplinary product development teams
Develop and implement global regulatory strategy to support expedited product development for one or more programs
Contribute to content and lead preparation of global product development plans and investigational / marketing applications, target product profiles, and pediatric study plans, as applicable
Research regulatory precedent and current/emerging trends related to product class and therapeutic area(s) to identify risks and opportunities for development/registration
Prepare team for and lead the conduct of milestone development and scientific advice meetings with global regulatory health authorities, including managing preparation of supporting meeting materials
Manage global regulatory lifecycle of assigned investigational products, including maintaining project timelines, organizing submission content, and coordinating the internal/external authoring and review of components of investigational drug applications, amendments, and safety and annual reports
Interface with external Regulatory Operations group in the compilation and e-submission of regulatory documents
Serve as primary liaison for communication with regulatory health authority on assigned programs
Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines
Participate in the development and review of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements
Assist in the archival and maintenance of regulatory application submissions and correspondence
Monitor company progress toward fulfillment of regulatory commitments

Skills

Regulatory Affairs

Regulatory Strategy

Global Regulatory

Health Authority Interactions

Regulatory Compliance

Strategic Planning

Cross-functional Leadership

Product Development

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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