Director Head of Regulatory Affairs

Were looking for a Director (Head) of Regulatory Affairs for our client Verismo Therapeutics!

Why Join Verismo

Verismos team is small but driven with the single focus of bringing lifechanging cell therapies to patients with cancer. With a solid pipeline built around a novel KIRCAR platform with two clinical trials underway their technology has found a way to circumvent the barriers in solid cancer where other CAR therapies have limited success. KIRCARs eliminate the artificial chimeric constructs within T cells and instead use a natural NKcell derived signaling system. This system is potent against both hematologic and solid tumors and in preclinical models is superior to current CAR T in conferring longterm sustained antitumor function to overcome the challenges posed in solid cancer. Verismo has a strong team for CMC clinical product manufacture and clinical investigators already established and moving fast to bring KIRCARs to patients in need.

Verismo is comprised of individuals who each bring something unique to the table and are valued for their contributions. Verismos culture is based on the concept of love what you do and the dedication that builds a team where people do their best and support one another. Because they believe their people are their greatest asset career development is an important aspect of their investment in their team and they encourage work/life balance.

About the Position:

Verismo Therapeutics is seeking a motivated and experienced Director/AD Regulatory Affairs to join our energetic and highgrowth team. This individual will report directly to our Chief Scientific Officer. The position responsibilities include development of Verismo s comprehensive regulatory strategy across pipelines and markets as well as handson work to draft edit and submit all necessary filings. This position will collaborate with internal and external functions including clinical nonclinical quality and CMC to drive forward Verismo s pipeline through development. This role will also be expected to remain abreast of changes in regulations to ensure that Verismo remains in compliance.

Essential Duties & Responsibilities:

• Develop implement and advise on regulatory strategies through all phases of development.
  
• Interface with Health Authorities as appropriate regarding development regulatory and registration strategies. Provide innovative and proactive regulatory leadership to project teams that align with development plans and corporate goals.
  
• Manage and ensure compliance with all reporting requirements including annual and periodic reports.
  
• Participate in the review of critical documents such as protocols ICFs IBs CSRs DSURs and so on to ensure compliance with relevant regulations and guidance (e.g. ICH FDA EMA) before submission.
  
• Lead the preparation and submission of all sections of all regulatory filings to regulatory authorities including but not limited to IND ODD Fast Track CTA and BLA applications and amendments or supplements either independently or with limited oversight.
  
• Prepare meeting requests and briefing documents and draft responses to questions and requests for information from regulatory authorities.
  
• Ensure adherence to current regulations associated with regulatory activities.
  
• Monitor changes in the regulatory environment both general and specific to the therapeutic area and support and advise the team accordingly.
  
• Keep current on FDA/EMA regulations ICH guidelines and other international regulatory regulations and guidelines as needed to support global programs.
  

Requirements

• Bachelor s degree in lifesciences or related scientific discipline; advanced degree preferred.
  
• 4 years in Regulatory affairs within pharmaceutical and/or biotechnology industry; experience in cell therapy preferred.
  
• Earlystage Oncology experience is required.
  
• Experience with earlystage cell therapy is required.
  

Preferred Experience & Abilities:

• Familiarity with the interpretation and application of relevant FDA guidelines pertaining to CMC nonclinical and clinical matters in drug development.
  
• Experience in preparation and submission of IND/CTA/NDA/MAA submissions with regulatory agencies and ability to contribute to the submission of global regulatory applications.
  
• Experience engaging with regulatory agencies at different stages and track record advancing compounds into and through the clinic.
  
• Demonstrated ability to handle multiple competing priorities prioritize multiple tasks and utilizing resources effectively.
  
• Specialized knowledge of global and regional regulatory affairs frameworks and guidelines.
  

Benefits