Director, Global Regulatory Affairs

Position Overview:

The Director, Global Regulatory Affairs is responsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for Vistagen’s products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of regulatory activities throughout the product lifecycle.

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Vice President, Global Regulatory Affairs.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

• Contribute to the regulatory strategy, development, and execution for Vistagen’s products, including nonclinical and clinical regulatory strategy, INDs, marketing applications, and post-approval changes.
• Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goals.
• Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies.
• Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policies.
• Oversee the preparation, review, and submission of regulatory submissions to health authorities.
• Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects.
• Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle.
• Act as a primary regulatory point of contact for IND(s) with the U.S. FDA.
• Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management.
• Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practices.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or related field. Advanced degree (Master’s, PhD, or PharmD) is preferred.
• 8-10 years of experience in Regulatory Affairs.
• Proven track record of successful regulatory submissions and approvals in relevant markets.
• Management and mentoring experience preferred.
• In-depth knowledge of regulatory requirements and guidelines (e.g. FDA, ICH).
• Experience with electronic submission systems (e.g. eCTD, SPL).
• Regulatory writing and liaison experience is required.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Strong problem-solving abilities and attention to detail.
• Strong project management and organizational skills.
• Ability to work under pressure and manage competing priorities.

Compensation and Benefits

What we offer:

• Industry competitive compensation
• Performance-based bonuses
• Stock options
• Employee Stock Purchase Plan
• 401k plan
• A collaborative and innovative work environment at the forefront of biotech advancements

Give your best, live wholesomely:

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HAS
• Basic Life Insurance 2x Earnings and AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-life balance:

• Unlimited paid time off
• Flexible work schedule
• Remote work option
• Paid holidays
• Mental health days
• Winter shutdown
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $185,000-$215,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally.

Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

All Employee’s have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA)

OVERVIEW OF THE COMPANY

Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate olfactory system and brain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.vistagen.com.

Salary : $185,000 - $215,000