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Director, Regulatory Affairs

Philadelphia, PA

About the Position

The Director, Regulatory Affairs will be a key member of the Development organization and interface with the project teams to manage regulatory aspects of projects related to clinical trials, health authority interactions and product approvals. The Regulatory Affairs Director works with medical/technical writing and Quality personnel to ensure compliance of submissions and programs with US, EU, and ICH requirements.

Responsibilities Include

  • Manage the regulatory aspects, as assigned, of projects/products including the preparation and submission of INDs/CTAs, amendments, correspondence, and meeting applications to regulatory agencies, including FDA, Health Canada, EMA, MHRA and other local European agencies.
  • Represent Regulatory Affairs and offer proactive solutions and regulatory guidance to cross-functional project teams at team/sub-team meetings as assigned.
  • Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities.
  • Coordinate and prepare responses to requests for information from Health Authorities.
  • Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.
  • Work with project teams and medical writing personnel to manage and submit product prioritization designation requests, e.g., orphan drug, fast track, regenerative medicine, PRIME, etc., in the US, Europe and Japan.
  • Work with medical writing and clinical personnel to manage Development Safety Update Reports and investigator brochures and ensure timely safety reporting to regulatory agencies.
  • Work with project teams to manage submission document preparation timelines and communicate with team members to maintain awareness of expectations, remove obstacles, enable timely reviews, achieve milestones, and document deliverables.
  • Liaison with Health Authorities as needed.
  • Work with the CMC team to manage preparation of CMC/Investigational Medicinal Product Dossier (IMPD) documentation and change control/annual reporting per health authority requirements.
  • Maintain archive and tracking of ongoing IND/CTA submissions, FDA/Health Authority communications and related issues to resolution.
  • Work directly with the electronic publisher to get submissions published and submitted.
  • Participate in direction/supervision of vendors involved in providing additional regulatory support.
  • Perform other related duties/responsibilities as required or assigned.

Required Qualifications

  • Degree in Biological Sciences; advanced degree in health sciences preferred, with at least 10 years of regulatory experience in the pharmaceutical industry (preferably Biotech).
  • Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics.
  • Expert knowledge of eCTD and filing of INDs. Experience with BLA filing preferred.
  • Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, CTAs, and MAAs and related health authority interactions is preferred.
  • Ability to support multiple projects and to prioritize work independently.
  • Confidence to present to management, peers, and scientific or business collaborators.
  • Strong written and verbal communication skills.
  • Strong team orientation and passion for continuous self-development.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.