Regulatory Specialist

Unique opportunity to join an exciting, mid-stage biotechnology company

Talaris Therapeutics, Inc.(“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ.  Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant.  In a ground-breaking, phase 2 study conducted between 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression.  We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years.  Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients.  Talaris recently closed a $100M private financing from leading life sciences investors. We will be initiating a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients later in 2019. We will also be initiating two Phase 2 trials of our therapy in additional indications in 2020.  Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.

The Regulatory Specialist willbe responsiblefor supporting project management of Regulatory submission deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, GMPs, GCPs, etc.). The specialist under the supervision of the Regulatory Director will support the technical preparation, submission, and archiving of all regulatory submissions prepared by Talaris Therapeutics and ensure that all submissions to regulatory authorities are produced on time per project timelines and comply with regulatory authority requirements. This newly created role will report to the Regulatory Director.

Responsibilities under the direction and in Support of the Regulatory Director

  • Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with regulatory authority requirements and company standards. Acts as direct liaison with contributing departments to facilitate effective management of submissions.
  • Oversee compliant submissions to global regulatory agencies including working with 3rd party resource for electronic publishing
  • Works independently with program and project teams to design and execute high quality submission plans, ensuring that timelines and technical requirements are mutually understood and in line with current standards
  • Represent Regulatory Operations on assigned teams Implement processes related to submission standards, working practices, and quality controls
  • Administer enterprise document management tasks including file transfer, off-site storage, tracking, and correspondence archival
  • Perform quality assurance of submission documents and published output including formatting, navigation, and dataset completeness
  • Maintains current regulatory knowledge of submission requirements, content, format and publishing for submissions to regulatory authorities, instructs the team of changes to process and implements appropriate regulatory strategies to mitigate risks
  • Ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines and for regulatory application types including INDs, NDAs/BLAs, MAAs, JNDA, NDS and any related amendments/supplements.
  • Defines and implements standards and process efficiencies for submission management including drafting and adherence of SOPs and work instructions; ensures application of best practices standards are understood and followed by applicable departments/stakeholders and vendors
  • Operates as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory staff and representatives from cross-functional teams
  • Oversees development and implementation of standards for publishing and submission process by assuring completeness and quality submissions from operational perspective and identifying solutions for regulatory submissions.
  • Oversees compliant archiving of all regulatory documents and regulatory correspondence, including developing archiving system and processes for regulating access to archives and overseeing maintenance of all correspondence logs.

Qualifications & Requirements

  • Minimum of 6 years of regulatory affairs operations experience required
  • Minimum of 4 years of CMC experience required
  • Minimum of bachelor’s degree in life sciences or technology-related discipline required
  • Demonstrated expert knowledge of regulatory submission including NDA, IND, IDE, MAA, CTA, CTD, NDS, CTN, JNDA, ACTD submissions and technological advancement on global authority guidelines & current regulations in drugs, medical devices and combination products, including experience in CMC.
  • Detailed knowledge and experience in global regulatory submission formats, industry standards, guidelines, validation concepts, and publishing best practices including eCTD format and registration tracking
  • Understanding of U.S. and international regulations including cGMP, GCP, GLP, ICH guidance documents
  • Excellent written and verbal communication skills
  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Demonstrated skills managing project timelines and organizing resources
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external customer groups.
  • Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and viewing tools.

Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com

Talaris is an equal opportunity employer and prohibits unlawful discrimination.