Director Regulatory Affairs

Location
Gaithersburg, MD
Posted
Jul 31, 2021
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

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:

  • 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.
  • Act as the primary contact with global regulatory authorities.
  • Oversee preparation of responses to all regulatory authority queries
  • Plan and lead meeting with regulatory authorities, including end of phase 1/2 meetings.
  • 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.
  • Responsible for building and maintaining key external relationships across regulatory agencies and key stakeholders.
  • Responsible for developing and cultivating a high performing regulatory team focused on accountability and meeting and exceeding expectations.
  • Participate in and conduct due diligence/licensing evaluations as necessary.
  • Develop CMC regulatory strategies and content plans.
  • Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to Cell Therapy and proteins.
  • Develop and execute global CMC regulatory strategy for Cell therapy product(s).
  • Provide accurate regulatory assessments of CMC changes to teams/projects and executes regulatory planning and implementation.
  • 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 EU and 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.