Boston, MA

Position: Regulatory Affairs (Director - Sr. Director)

Position Summary

Reporting to the Senior Vice President of Regulatory Affairs and Quality Assurance, this critical position will be responsible for developing and implementing strategic and operational regulatory plans for the current and future indications for Karuna’s development assets and any future marketed products. The incumbent will play a critical role in the filing and approval of Karuna’s marketing applications (NDA, MAA). The individual will also play an important role in maintaining effective communication and constructive working relationships with both internal and external collaborators and regulatory authorities. The individual will also have the ability to contribute to building the organization as the Company grows, further advancing their leadership position.

Responsibilities

• Lead NDA submission-related initiatives, including label development and FDA Advisory Committee preparations.
• Manage and lead regulatory projects, providing strategic leadership and operational excellence.
• Develop appropriate regulatory strategies for projects at all stages of development, in collaboration with cross-functional members in areas such as medical, CMC, preclinical and project management.
• Lead FDA meetings for assigned projects, including the preparation of briefing materials, team preparation, meeting execution and follow-up communication of outcomes to Karuna stakeholders.
• Interact with regulatory agencies with intelligence, diplomacy, and a tone that conveys collaboration and partnership. Develop and maintain strong relationships with regulatory agency staff.
• Utilize development expertise to advise teams on broader development issues. Provide a big picture, unbiased perspective in all development discussions, seeking approvable development packages capable of commercial success.
• Collaborate with third party regulatory and regulatory CMC consultants, and CRO’s to supplement expertise and operational capacity.
• Serve as the subject matter expert on regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide the overall development plans accordingly.
• Proactively monitor changes in the regulatory environment and provide recommendations to R&D staff on how to address them appropriately, including modifications to development plans.

Required Qualifications

• PhD or Master’s degree in a relevant scientific area.
• 10+ years of bio/pharmaceutical experience in drug development with progressively increasing responsibilities in regulatory affairs.
• Psychiatry, Neurology, and Pain development experience, with a significant level of interaction with the relevant FDA review divisions highly preferred.
• Experience working with the FDA is required. Global regulatory clinical trial experience and regulatory CMC experience are highly preferred.
• Deep regulatory experience is essential, including experience with developing broad plans for phase 3 pivotal trials and product registration and NDA regulatory experience in a relevant FDA review division.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Attention to detail and quality are critical to success.
• Able to command respect from peers and capable of highly independent work as well as being a team player and role model.
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
• Proven ability to manage multiple projects, identify and resolve issues.
• Broad experience in a small company environment is a plus.
• Ability to travel up to 25%.

The successful candidate will also embody our values:

Our purpose is to create value for those we have the privilege to serve:

• We take pride in our work
• We keep our promises and deliver
• We are driven to meaningfully innovate
• We succeed through inclusion and teamwork

Karuna Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Karuna Therapeutics requires all employees be fully vaccinated by an approved vaccine against COVID-19, including a booster dose if it has been more than eight months since the employee’s original vaccination, unless you need an exemption due to disability, pregnancy or conditions related to pregnancy or religion or unless otherwise provided by law; in the case of exemption, weekly testing will be required.