Position Overview:

The Vice President/Senior Vice President, Global Regulatory Affairs will lead our regulatory strategy, ensuring compliance with global regulations. This team member will lead strategy, preparation and submission of regulatory documents, including NDA, IND, and other submissions. Working with the cross-functional development team, they will lead all Health Authority meetings associated with the program, hold accountability for the program’s global regulatory plan and its execution, identify and assess regulatory risks associated with planned clinical development activities and provide technical advice and counsel. This is a critical leadership role within the company and has a significant influence on the achievement of corporate and program objectives and key results.

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 Chief Operating Officer.  

Key Duties & Responsibilities:

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

  • Lead the global regulatory strategy for the assigned product(s), accountability for ensuring that plans meet global regulatory requirements.
  • Work cross-functionally with other internal departments and external partners to develop, strategize, and submit regulatory documents (NDA, IND, etc.).
  • Lead Health Authority meeting planning, preparation, and conduct; accountable for the delivery of optimal meeting outcomes.
  • Proactively identify and assess regulatory risks associated with planned clinical development activities.
  • Review and approve all submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, development safety update reports, and other documents as needed.
  • Support strategy for providing submission of CMC and non-clinical information.
  • Act as the independent subject matter expert in giving guidance to project teams, departments, and management; provide strategic counsel to C-Suite executives.
  • Contribute to the development of target product profile and draft labeling.
  • Stay current with evolving regulatory requirements and industry trends, interacting with regulatory agencies and ensuring the company’s compliance with global regulations.
  • Provide training and education on regulatory topics to internal stakeholders.
  • Recruit, mentor, and develop a high-performing regulatory team, fostering a collaborative and innovative work environment.
  • Serve as the primary point of contact with the FDA and other health authorities, as applicable.

Qualifications:

  • Advanced degree in science (Ph.D., MD, PharmD) in a relevant scientific discipline.
  • 15+ years of industry experience with a minimum of 10+ years of progressive leadership experience in regulatory affairs within the biotechnology or pharmaceutical industry.
  • Proven experience with various Phase I-III and NDA submissions with a preference for recent, successful approval.
  • Broad regulatory background with ability to act as both a generalist and specialist depending on what’s needed.
  • Significant experience with US FDA regulations; strong understanding of Global Health Authority policies, laws, regulations, and guidelines as they apply to drug development and approvals.
  • Significant knowledge of the drug development process (early-stage through commercialization).
  • Exceptional leadership, communication, negotiation, and stakeholder engagement skills.
  • Demonstrated ability to prepare for launch readiness.
  • Ability to travel up to 15-20% (US and international).

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 $300,000-$400,000 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

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 rain 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.

 

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