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 SummaryThe 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 ResponsibilitiesRegulatory 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
QualificationsEducation- 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.
