Senior Director/ Executive Director, Regulatory Affairs

San Diego, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

The ideal candidate should possess a Bachelor's or Master's degree in a relevant scientific or regulatory field, and demonstrate extensive experience leading regulatory teams with a proven record of successful regulatory submissions. Strong knowledge of FDA and EMA regulations, clinical trial regulations, and global regulatory requirements is essential, along with experience in preparing and managing IND/CTA, NDA/BLA/MAA submissions and amendments.

Responsibilities

As the Executive Director/Senior Director, you will lead the Regulatory Affairs team in managing clinical regulatory activities, setting regulatory strategy, and directing the planning and execution of clinical trials to secure regulatory approvals. This includes providing cross-functional leadership for global filings, authoring/reviewing regulatory documents, mentoring staff, and serving as the primary contact with regulatory authorities. You will also be responsible for providing regulatory input on clinical study protocols, conducting due diligence, leading health authority meetings, and overseeing departmental strategies and compliance.

Skills

Regulatory Affairs

FDA

EMA

IND/CTA

NDA/BLA/MAA

Clinical Trials

Marketing Authorization

Global Filings

Due Diligence

Product Integrations

Clinical Study Protocols

ICFs

SAPs

CSRs

Health Authority Guidance

Cross-functional Leadership

Team Leadership

Strategic Planning

Process Development

SOP Development

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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