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

Remote

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

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 and broad experience with 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 (inferred from incomplete text)
Experience with biologics and combination products
APFS or Auto-Injector experience highly preferred
Effective communication skills

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
Contribute to global regulatory strategies and collaborate with key stakeholders to execute the strategies in alignment with business priorities
Provide guidance to cross-functional colleagues throughout the design specification, design verification, design validation, and process validation, contributing to risk assessments and planning

Skills

Key technologies and capabilities for this role

Regulatory AffairsCombination ProductsBiologicsCMCAuto-InjectorAPFSDevice DevelopmentDevice QualityDesign VerificationDesign ValidationProcess ValidationGlobal Regulatory Strategies

Questions & Answers

Common questions about this position

Is remote work allowed for this position?

Yes, the company is open to you working remotely.

What experience is required for this role?

You must have experience with biologics and combination products, with APFS or Auto-Injector experience highly preferred.

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 core principles at the center of operations, with the goal to elevate the care of patients’ lives, in a dynamic environment.

What skills make a strong candidate for this role?

Strong candidates will have experience with biologics and combination products (especially APFS or Auto-Injector), effective communication skills, and the ability to develop global regulatory strategies and interpret regulations.

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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