Director, Regulatory Affairs

Location
Cambridge, Massachusetts
Posted
Oct 12, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Summary

Casebia Therapeutics is seeking a Director, Regulatory Affairs with a passion for delivering breakthrough therapeutics to patients.  The candidate will play an integral part in the Regulatory team and will support development of life-changing therapies using Casebia’s proprietary gene-editing technology.  The ideal candidate will have at least 10-15 years in drug development (minimum 10 years in Regulatory Affairs) within the biotech or pharma industries.   Experience in orphan drug development and early stage drug development is desired, as demonstrated by successful IND/CTA submissions supporting the transition of a preclinical product from the bench to the clinic.  Experience with gene editing/ gene therapy / biologic drug development is a plus. The ideal candidate will be agile, self-motivated, and have a proven record in a fast- paced environment.  He/she will report to the Head of Regulatory.

Job Responsibilities

Develop and implement global regulatory strategies for early pre-clinical stage assets through clinical /development registration plans. Responsible for establishing regulatory engagement approaches to set strategic direction for the early pipeline.  This includes preparation of briefing books to support Health Authority meetings as well as writing to support IND/CTA submissions.

  • Identify and assess opportunities for innovative and risk-forward regulatory approaches to support effective and efficient product development. Define strategies to mitigate risks.
  • Monitor and analyze regulatory agency activities across areas of interest, assess impact on products and portfolio, and propose strategies to address
  • Provide strong leadership on project teams in all areas of regulatory science and product development
  • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
  • Direct the project teams to prepare clear and effective submissions to health authorities
  • Prepare and deliver effective presentations for external and internal audiences
  • Provide input to senior management teams
  • Foster a global view as part of a collaborative regulatory team
  • Actively participate in and contribute to regulatory policy development

Required Skills & Qualifications

  • PhD/PharmD in a Life Science or equivalent preferred, Master’s or Bachelor’s Degree considered based on experience level
  • Minimum 10 years of regulatory affairs leadership experience in a clinical stage pharmaceutical or biotechnology company.  
  • Candidate who sees big picture but who also likes to roll up their sleeves is preferred
  • Demonstrate previous experience guiding and motivating regulatory and development teams as well as direct experience with regulatory submissions and product development, including leading submissions to the US FDA (IND, NDA, BLA), EMA (MAA) and EU National Health Authorities (IMPD/CTA)
    • Developing and implementing global regulatory strategies
    • Leading regulatory submissions to support product development, including INDs/CTAs, NDA/BLA/MAAs)
    • Leading successful, effective meetings /discussions with Health Authorities
  • Thorough knowledge of the drug development process, including clinical research, study design, biostatistics, and the regulatory environment
  • Knowledge of biologics development
  • Deep and broad knowledge of US approvals; experience in the interpretation of US, EMA, ICH, and international regulations, guidance documents, etc.
  • Understanding of the level of evidence required to achieve regulatory, goals with an appreciation of market access and commercial goals
  • Ability to interpret and present clinical data and other complex information
  • Demonstrated ability to communicate clearly, concisely, and effectively
  • Ability to work effectively with limited direction and guidance and minimal supervision, to set priorities and multi-task to meet timelines in a fast-paced and demanding environment
  • Willingness and ability to travel, including international, is required