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Director, Regulatory Affairs

Employer
Arcellx Inc.
Location
Gaithersburg, MD
Start date
Sep 10, 2021

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company has a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells. Arcellx's vision is to bring ARC-sparX platform cell therapies to millions of patients who can self-administer prescribed sparX proteins under the care of academic and community practices.

Primary Objective

Arcellx is seeking a Director of Regulatory Affairs who will help lead and drive the company's regulatory approval strategy and implementation, as well as overseeing post-approval regulatory requirements. This individual is expected to cultivate productive relationships with regulatory authorities. Leading a small team, this individual is expected interface and effectively communicate with cross-functional members of the Arcellx team. The incumbent fulfills a critical and highly visible role, making substantial contributions to the company.

Main Accountabilities:

  • Develop and execute global regulatory strategies.
  • Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications.
  • Establish regulatory strategies for programs including non-clinical study plans, regulatory requirements for clinical studies and marketing approvals.
  • Oversee preparation of responses to regulatory authority queries
  • Plan and lead meetings with regulatory authorities, including end of phase meetings, pre-submission meetings, etc.
  • Prepare for and lead the organization during regulatory inspections.
  • Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine including accelerated review programs.
  • Manage critical regulatory issues and work with team members to resolve issues related to CMC, non-clinical studies, and clinical development.
  • Collaborate with external consultants, clinicians, CROs to provide regulatory guidance.
  • Manage and monitor preparation of high-quality regulatory submissions.
  • Participate in and conduct due diligence/licensing evaluations as necessary.
  • Support internal develop and manufacturing teams and provide direction on the interpretation and application of global regulations and guidance related to Cell Therapy and proteins.
  • Escalate issues to Management that affect registration, regulatory compliance and continued lifecycle management of the product.

Preferred Qualifications:

  • A minimum of a Bachelor's and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required.
  • A minimum of 10+ years of experience inclusive of postgraduate education and/or pharmaceutical or health care industry experience or equivalent is required.
  • A minimum of 10 years of experience developing or contributing to global regulatory strategies while working in a regulatory affairs or related function (i.e., R&D, quality, reg compliance) is required.
  • Experience in biologics is required.
  • Knowledge of FDA regulations is required.
  • Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is highly preferred.
  • Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. is highly preferred.
  • Good understanding of regulatory precedent in the area and requirements for early/late development is preferred.
  • Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required.
  • Experience leading interactions with Health Authorities is required.
  • An understanding of health authority laws, regulations, guidance and regulation submission routes available for assigned products is preferred.

Competencies:

  • Commitment to ethical scientific investigations and rigorous experimental methods.
  • Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
  • Sense of urgency in performance of duties.
  • Interpersonal skills that promote a collaborative and productive lab environment.
  • Effective and efficient written and oral communication skills.

Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.

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