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Job

Senior Director, Regulatory Affairs CMC

  • Location

    Hybrid

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    9 days ago

  • Expiry date:

    2022-07-10

  • Startdate:

    ASAP

A biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted cellular immunotherapies  for cancer and other serious diseases. As a company rapidly moving towards the clinical stage, we are growing and seeking an experienced and talented Director/Senior Director of Regulatory - Chemistry, Manufacturing & Controls (CMC) to develop and lead the regulatory activities associated with CMC for all programs. Reporting into Vice President, Regulatory Affairs, the Director/Senior Director, Regulatory CMC, leads the execution of global regulatory CMC strategies for investigational cell therapy products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development of the cell therapy products. You will coordinate and oversee CMC regulatory activities across functions in the organization, including R&D (when applicable), TechOps, Quality, Clinical and external consultants, and partners to execute on our strategic plan to meet corporate goals.

Responsibilities

  • Partnering with global health authorities and developing creative & innovative strategies that progress current thinking on regulatory requirements related to CMC aspects of cell therapies in development
  • Ensuring that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures, scientific advice/meeting requests, and agency briefing documents, are complete, well written, and meet all relevant requirements
  • Partnering with cross-functional partners including, but not limited to, R&D (when applicable), TechOps, Quality, Clinical and Regulatory leadership and external partners
  • Effectively communicating regulatory CMC strategy, risks, mitigations, and overall plans to regulatory leadership team, project team, and executive team, external partners, as relevant.
  • Driving adherence to CMC regulatory guidelines relevant for the development of cell therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
  • Contributing to regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to various internal teams and external partners as necessary
     

Requirements

  • Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
  • 10+ years of relevant biopharmaceutical industry experience, with 10+ years' experience in CMC-focused Regulatory Affairs for biologics or 5+ years' experience in CAGT/ATMPs
  • Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, EMA, and FDA guidelines. Experience with the NPMA (National Medical Products Administration) in China, and other international regulations is ideal
  • Experience in leading CMC topics at Health Authority meetings
  • Excellent communication skills with the ability to influence across all functions and levels within the organization and with external stakeholders
  • Excellent written and communication skills, strong technical knowledge, including CMC regulatory writing and ability to influence across multiple functions
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze and creatively solve challenging problems
  • Strong organizational skills with the ability to prioritize, multi-task, and work in an evolving and fast-paced environment
     

Physical Demands

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
  • The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.
  • Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
  • This position requires the ability to occasionally lift and/or move up to 25 pounds.
     

Work Environment

  • Will require working with cells and cell lines of human and/or animal origin.
  • Will require working with hazardous materials.
  • Work in and around common laboratory equipment.
  • The regular requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around a laboratory environment.
  • 100% on-site work at corporate headquarters in San Diego, CA. Hybrid work environment available if not located in San Diego, CA.
  • Evening and weekend work as necessary.

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