Director/Senior Director, Regulatory Affairs Strategy

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: Director/Sr Director, Regulatory Affairs Strategy      

Location: Hybrid in Menlo Park, CA -or- Waltham, MA   

Role Overview: The Director/Sr Director, Regulatory Affairs Strategy provides global regulatory oversight and project leadership of assigned development products and reports to the Vice President Regulatory Affairs. This role involves contributing to and implementing regulatory strategies and plans to expedite global product development, managing regulatory communications/interactions with health authorities, and ensuring compliance with applicable regional regulations. This position will interface closely with the cross-functional Development team, as well as with external consultants and advisors, to ensure regulatory plans and strategies are well integrated and supportive of overall corporate objectives.

Strategic Planning

• Serve as Regulatory Affairs lead on multidisciplinary product development teams
• Develop and implement global regulatory strategy to support expedited product development for one or more programs
• Contribute to content and lead preparation of global product development plans and investigational / marketing applications, target product profiles, and pediatric study plans, as applicable
• Research regulatory precedent and current/emerging trends related to product class and therapeutic area(s) to identify risks and opportunities for development/registration
• Prepare team for and lead the conduct of milestone development and scientific advice meetings with global regulatory health authorities, including managing preparation of supporting meeting materials.

Regulatory Operations

• Manage global regulatory lifecycle of assigned investigational products, including maintaining project timelines, organizing submission content, and coordinating the internal/external authoring and review of components of investigational drug applications, amendments, and safety and annual reports
• Interface with external Regulatory Operations group in the compilation and e-submission of regulatory documents
• Serve as primary liaison for communication with regulatory health authority on assigned programs

Compliance

• Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines
• Participate in the development and review of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements
• Assist in the archival and maintenance of regulatory application submissions and correspondence
• Monitor company progress toward fulfillment of regulatory commitments

Qualifications

Education

• Bachelor’s degree in a life sciences discipline; advanced degree preferred; Regulatory Affairs Certification (RAC) a plus

Experience

• Minimum 8 years progressive pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics
• Direct and recent experience in preparation, submission and lifecycle management of global investigational/marketing applications submitted outside North America, including as primary Regulatory author
• Experience negotiating and directly interfacing with US and international regulatory authorities
• Product development in therapeutic areas of dermatology, immunology or inflammation a plus

Skills

• In depth knowledge of GXP/ICH guidelines and global regulations and sy