Sr. Manager/Associate Director, Regulatory Affairs

About us

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

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.

Job Title: Sr. Manager/Associate Director, Regulatory Affairs

Location : Preferred: Hybrid 3 days/week in office (Menlo Park, CA or Waltham, MA). Remote will be considered.

Position Summary

The Senior Manager / Associate Director, Regulatory Affairs will support regulatory activities for one or more development programs and contribute to the development and execution of global regulatory plans that support the advancement of Oruka’s biologics portfolio. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.

The successful candidate will be a collaborative partner who can balance strategic thinking with strong operational execution in a fast-paced biotechnology environment.

Key Responsibilities

Regulatory Development Support

Serve as a regulatory representative on multidisciplinary program teams for one or more investigational products

Contribute to the development and execution of global regulatory plans aligned with program objectives and development timelines

Support regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle management

Evaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning

Partner closely with cross functional development team and program leadership to support development objectives and regulatory requirements

Support regulatory assessments related to development pathways, expedited programs, pediatric requirements, and regional filing considerations

Health Authority Interactions

Support the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements

Contribute to the development of briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications

Participate in interactions with health authorities and support follow-up activities and action plans

Help translate regulatory feedback into clear recommendations for cross-functional teams

Submissions and Regulatory Execution

Independently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documents

Contribute to major regulatory submissions and health authority deliverables for assigned development programs

Coordinate submission planning, timelines, content development, and review activities

Partner with Regulatory Operations and external vendors to support dossier planning, publishing, and electronic submissions

Ensure regulatory documents are scientifically accurate, compliant, and aligned with development objectives

Regulatory Compliance

Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs

Support compliance with applicable regulations, ICH guidelines, and company procedures

Contribute to the development and continuous improvement of regulatory processes, templates, and SOPs

Assist with tracking and fulfillment of regulatory commitments

Leadership and Collaboration

Build strong partnerships across functional teams through effective communication and collaboration

Provide regulatory input and risk-based recommendations to support cross-functional decision-making

Qualifications

Education

Bachelor’s degree in a life sciences discipline required

Advanced degree (MS, PharmD, PhD, or equivalent) preferred

RAC certification is a plus

Experience

8 - 10 years of progressive Regulatory Affairs experience in biotechnology or pharmaceutical development

Experience supporting regulatory activities for drugs and/or biologics in clinical development, including health authority interactions and global submissions

Experience authoring and/or coordinating regulatory submissions and agency briefing documents

Experience in dermatology, immunology, inflammation, or related therapeutic areas is advantageous

Skills

Strong understanding of global regulatory requirements, including US/EU regulations, ICH guidelines, and ex-US development considerations for drugs and biologics

Ability to interpret regulatory guidance and apply it in a practical, risk-based manner

Excellent communication, collaboration, organizational, and project management skills

Strong scientific and analytical thinking with the ability to connect regulatory requirements to development objectives

Ability to manage multiple priorities and work effectively in a dynamic environment

Willingness to travel up to 20%

Compensation

An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.

The anticipated salary range for the Senior Manager level is $161,000 - $187,000 and the Associate Director level is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

What We Offer

Competitive salary and benefits package

Eligibility for matching 401(k) and participation in ESPP

Comprehensive health, dental, vision, and life insurance

Flexible working arrangements

A collaborative, mission-driven culture

The opportunity to play a meaningful role in advancing a differentiated biologics portfolio with the potential to redefine treatment expectations for patients with chronic skin diseases

This role is ideal for a regulatory professional who enjoys working across multiple aspects of Regulatory Affairs and wants to play a meaningful role in advancing innovative therapies through clinical development and regulatory approval.

Salary Range For the Role $161,000 — $208,000 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.

Department: Regulatory Affairs.

ATS provider: Greenhouse.

Salary: salary range for the Senior Manager level is $161,000 - $187,000 and the Associate Director level is $182,000 - $208,000.