[Remote] Senior Director, Regulatory Combination Product at Abata Therapeutics

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Requirements

Bachelor’s degree in a scientific/engineering discipline
Experience as regulatory lead in pharmaceutical, biotechnology, or medical device industries, specifically with combination product filings
Strong knowledge of regulations, standards, directives, guidelines and requirements related to the use of combination products in global clinical studies and commercial registration
Proven track record in late‑stage development of combination products
In-depth understanding of ISO

Responsibilities

Develop comprehensive strategies that address both biologic and device components and align with corporate goals and regulatory expectations
Provide guidance for plans and protocols for compatibility studies, design verification studies and functional stability studies, and contribute to the design of human factor studies and usability testing
Interpret regulatory regulations, standards, directives, guidelines and advise Development, Technical Operations, and Quality on their applicability to and impact on product development projects
Deliver strategic input to Design Control processes and documentation, ensuring alignment with health authority and notified body requirements and global technical standards. Review DHF documentation from a regulatory perspective
Design and execute effective submission strategies for device-related dossier components (INDs/CTAs, marketing applications, and post-approval changes) in collaboration with SMEs
Conduct precedent research to ensure creation of state-of-the-art studies
Influence cross-functional decision-making without direct authority, operating effectively in a matrixed environment
Perform assessment of change controls to identify and mitigate regulatory risks
Lead interactions with health authorities and notified bodies
Help manage device-related regulatory information in company systems
Support for other Regulatory CMC activities

Skills

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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