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Director/Senior Director, Regulatory Affairs Strategy

Menlo Park, California, United States

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 systems
  • Ability to interpret and apply complex and evolving regulatory guidance
  • Strong written and verbal communication, analytical, organizational and interpersonal skills
  • Excellent strategic planning and cross-functional project management skills
  • Ability to work in a dynamic, fast paced environment with a high degree of flexibility
  • Ability and 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 candidates, who will work in Menlo Park, CA -or- Waltham, MA is $205,000275,000. 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.

Job Location:

  • Hybrid candidates will be required to be in-office in 3 days/week in either Menlo Park, CA or Waltham, MA.

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.

Salary Range For the Role

$205,000 - $275,000 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.

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