Head of Regulatory

About Us:

Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts. We have a lead program that we expect will be in the clinic in 2025 and could offer transformative efficacy for a disease that affects millions of people.

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Position Overview:

We are seeking a highly motivated individual to head up the Regulatory Affairs function. The candidate will be responsible for leading the Regulatory Affairs function and will oversee and direct the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization. This role involves extensive interaction with regulatory agencies especially with the FDA, seeking scientific advice and approvals, and provides cross-functional leadership for filings, ensuring compliance with local regulatory requirements and authoring and reviewing submission documents for regulatory applications. The ideal candidate will have a successful record of approved regulatory submissions.

Key Responsibilities:

• Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
• Interact with the FDA and other regulatory agencies to seek scientific and regulatory advice and obtain required approvals.
• Provide strong cross-functional leadership for global filings including authoring and reviewing sections of IND, CTA, NDA, MAA, and other global submission documents in support of clinical trials and marketing applications, as well as their amendments, in conformance with local regulatory requirements.
• Develop and implement cross-functional department policies, processes, work instructions, and standard operating procedures.
• Provide regulatory leadership for due diligence activities and partnering activities.
• Ensure inspection readiness efforts for regulatory activities and files.
• Manage regulatory budgets and vendors.
• Maintain current expertise in regulatory trends and operations.
• Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science.

Qualifications:

• Bachelor's degree required, with an advanced scientific degree (PhD, PharmD, MD) strongly preferred.
• 15 years or more of experience leading Regulatory Affairs function and people management experience.
• Extensive regulatory experience with clearing INDs and CTAs and gaining approvals of NDAs and MAAs.
• Demonstrated proficiencies in leading successful health authority meetings.
• Experience with autoimmune products and interacting with FDA CBER and EMA; additional experience with the FDA dermatology division is a plus.
• Experience in leading multidisciplinary teams.
• Strong knowledge in clinical and nonclinical regulatory science.
• Knowledgeable regarding global regulatory submission standards and publishing best practices.

Skills and Abilities:

• Excellent communication and collaboration skills across levels and functions.
• Ability to work independently and collaboratively in a highly dynamic work environment.
• Strong initiative, accountability, and willingness to take ownership and drive projects to completion.
• Ability to set priorities, work independently and deliver results in a timely manner.
• Sound strategic, technical, operational, and ethical judgment with uncompromising integrity.
• Travel, including international travel, approximately 25%.

Salary Range for the Role

$315,000-$330,000 USD

What We Offer:

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.