[Remote] Senior Director, Regulatory Affairs at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor's degree and a minimum of 10 years of direct experience in Regulatory Affairs; rare disease, neurology, CMC, advanced degree (MS, PharmD, PhD), and/or combination product experience a plus
Demonstrated track record of successful interactions with FDA and other Health Authorities
Expert understanding of scientific principles and regulatory requirements relevant to global drug development
Preparation of nonclinical and clinical sections of regulatory filings, including IND/CTAs, PIPs, briefing documents, and BLA/MAAs
Preparation for and conduct of Regulatory meetings with global Health Authorities for complex issues
Strong interpersonal skills and the ability to collaborate effectively with subject matter experts

Responsibilities

Represent regulatory on cross-functional teams; provide leadership and strategic direction for regulatory deliverables
Lead planning and provide hands-on support for development and on-time delivery of clear and persuasive global regulatory submission documents, including INDs/CTAs, DSURs, pediatric investigation plans (PIPs), responses to Health Authority (HA) queries, and briefing documents
Identify, communicate, and propose resolutions to routine and complex strategic issues
Serve as primary contact and build trusted relationships with Health Authorities for assigned program(s)
Maintain expert knowledge in US and international regulations and provide proactive regulatory intelligence
Assess opportunities and oversee applications for expedited pathways (eg, fast track or breakthrough designation or PRIME) and/or orphan drug designations
Lead preparation for and conduct of Health Authority meetings
Evaluate competitive landscape, regulatory approval pathway(s), and labeling precedent(s)
Identify, engage and collaborate with external regulatory experts and consultants
Perform regulatory strategic assessments for new product candidates and new indications
Support departmental initiatives, including process and infrastructure development, regulatory intelligence, budgeting, and authoring of departmental documents (eg, SOPs and Regulatory Development Plans)

Skills

Key technologies and capabilities for this role

Regulatory AffairsGlobal Regulatory StrategyRegulatory SubmissionsHealth Authority LiaisonRegulatory ComplianceCross-Functional Leadership

Questions & Answers

Common questions about this position

Is remote work allowed for this position?

Yes, the role is open to remote work within the United States.

What are the key responsibilities of the Senior Director of Regulatory Affairs?

The role involves developing global regulatory strategies, leading cross-functional teams, managing regulatory submissions like INDs/CTAs and DSURs, serving as liaison with Health Authorities, and providing regulatory intelligence.

What experience is needed for this regulatory affairs role?

Expertise in US and international regulations, experience with global regulatory submissions, Health Authority interactions, and strategic assessments for expedited pathways and orphan designations is required.

What is the company culture like at Abata Therapeutics?

The company is building a culture centered on core principles to elevate patient care, within a growing organization with an expanding pipeline.

What makes a strong candidate for this Senior Director role?

Candidates with experience leading global regulatory strategies, hands-on submission expertise, Health Authority relationship-building, and regulatory intelligence in autoimmune or similar programs will stand out.

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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