Senior Manager/Associate Director, Regulatory Affairs

Oruka Therapeutics

Senior Manager/Associate Director supporting regulatory activities for biotech development programs. Collaborating on global regulatory plans and health authority interactions while ensuring timely submission of regulatory applications.

Posted 6/6/2026full-timeMenlo Park • California, Massachusetts • 🇺🇸 United StatesSenior💰 $161,000 - $208,000 per yearWebsite

About the role

Key responsibilities & impact

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 the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements
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
Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs

Requirements

What you’ll need

Bachelor’s degree in a life sciences discipline required
Advanced degree (MS, PharmD, PhD, or equivalent) preferred
RAC certification is a plus
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
Strong understanding of global regulatory requirements, including US/EU regulations, ICH guidelines, and ex-US development considerations for drugs and biologics
Ability to manage multiple priorities and work effectively in a dynamic environment
Willingness to travel up to 20%

Benefits

Comp & perks

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

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Hard Skills & Tools

regulatory submissionINDsCTAsregulatory documentsglobal regulatory plansclinical developmentregulatory activitiesauthoringcoordinationhealth authority interactions

Soft Skills

ability to manage multiple prioritieswork effectively in a dynamic environmentcollaborationcommunicationproblem-solvingleadershiporganizational skillsadaptabilityattention to detailstrategic thinking

Certifications

Bachelor’s degree in life sciencesMSPharmDPhDRAC certification