Director, Regulatory Affairs - CMC
Rubius Therapeutics
 Cambridge, MA
Rubius Therapeutics is a rapidly-growing, clinical-stage biopharmaceutical company that is genetically engineering red blood cells into an entirely new class of allogeneic, off-the-shelf cellular medicines.  Our Red Cell Therapeutics™ (RCTs) can potentially be used to replace missing enzymes for patients living with rare enzyme deficiencies, kill tumors in cancer and regulate the immune system for the treatment of autoimmune diseases.  Our first RCT™ product candidate is RTX-134 for the potential treatment of phenylketonuria, a rare metabolic disorder.  We expect to report initial clinical data by the end of 2019 from our Phase 1 clinical trial.  Additionally, we plan to file our first oncology Investigational New Drug (IND) application for RTX-240 for the treatment of solid tumors by early 2020.  In total, we plan to file four to five INDs during 2019 and 2020.

We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are based in Cambridge, MA and currently expanding across all functions within the organization.  Having completed our initial public offering in July 2018, (Nasdaq:RUBY), we are well capitalized to execute our vision of creating life-changing cellular medicines. Red blood cells are no longer just for carrying oxygen.  At Rubius, we are transforming them into medicines.  Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn.

Summary
We are looking for a Director, CMC Regulatory Affairs to join our team and provide regulatory CMC leadership in support of the cellular therapy development programs at Rubius Therapeutics, Inc. The successful candidate will provide the strategic guidance for global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval and ultimately support the life-cycle of approved products. This person represents the regulatory function on multi-disciplinary product development teams and with external entities.  The person in this role serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities. This includes developing and implementing the strategic CMC plans in collaboration with the Technical Operations and Quality Assurance teams, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.  

Responsibilities

  • Lead CMC Regulatory Affairs activities in line with US, European, ICH, and other applicable regulations.
  • Coordinate with Technical Operations, Quality Assurance, and other functional areas to implement CMC regulatory strategy.
  • Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and submission of marketing applications.
  • Represent the regulatory function on development teams providing CMC regulatory guidance and strategy.
  • Ensure that regulatory documents are accurate, complete and in compliance with applicable regulatory requirements.
  • Support the implementation of manufacturing processes, testing and process changes in accordance with cGMP and assessment of regulatory implications
  • Maintain current knowledge of relevant guidelines and regulations, determine the applicability to Rubius Therapeutics programs and communicate this information to team members
  • Interface with regulatory authorities to drive development programs including preparing meeting requests and briefing documents, and coordinating and preparing teams for meetings with regulatory authorities
  • Represent the regulatory function on cross-functional product development teams 

Qualifications & Education

  • BA/BS in life science or health related field, advanced degree preferred
  • 10+ years of CMC regulatory affairs experience in the biopharmaceutical industry
  • Experience in the development of cell or gene therapies strongly preferred
  • Experience in providing strategic advice on the CMC regulatory development plans and executing the regulatory strategy
  • Strong knowledge and experience in CMC product development and in-depth working knowledge of applicable regulations, guidance and procedures
  • Previous experience in the preparation and submission of regulatory documents (IND/CTA/NDA/BLA/MAA)
  • Prior experience in regulatory agency engagement and interaction
  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective
  • Strong verbal and written communication skills
EEO Statement: Rubius Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Recruitment & staffing agencies: Rubius Therapeutics does not accept agency resumes unless contacted directly by internal Rubius Talent Acquisition. Please do not forward resumes to our careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.