Head of Regulatory Affairs

3 weeks ago

San Diego, United States KayeBassman International Full time

Position Title: Head of Regulatory Affairs


Location: Southern California


Company Overview: We are partnered with a cutting-edge pre-IPO cell therapy company dedicated to transforming the lives of patients with cancer and autoimmune diseases. There innovative pipeline harnesses the power of cellular therapies to provide groundbreaking treatment options. As they prepare for their next phase of growth and the upcoming IPO, they are seeking a dynamic and experienced Head of Regulatory Affairs to join their team in Southern California.


Position Summary: The Head of Regulatory Affairs will be a key member of the executive team, responsible for developing and executing regulatory strategies to support the clinical development and commercialization of our cell therapy products. This individual will ensure compliance with all relevant regulations and guidelines, working closely with regulatory agencies, internal stakeholders, and external partners. The successful candidate will have a strong background in regulatory affairs within the biopharmaceutical industry, with specific experience in oncology and autoimmune diseases.


Key Responsibilities:

  • Develop and implement comprehensive regulatory strategies to support the clinical development, approval, and commercialization of the company’s cell therapy products.
  • Lead interactions and communications with regulatory agencies (FDA, EMA, and other global regulatory bodies) to facilitate timely approvals and ensure compliance with regulatory requirements.
  • Oversee the preparation, submission, and maintenance of regulatory documents, including INDs, BLAs, MAAs, and other regulatory filings.
  • Provide regulatory guidance and expertise to cross-functional teams, including clinical development, manufacturing, quality assurance, and marketing.
  • Monitor and interpret regulatory requirements and trends, ensuring that the company’s regulatory strategies and activities are aligned with current guidelines and best practices.
  • Manage regulatory risk assessments and develop mitigation strategies to address potential regulatory challenges.
  • Build and maintain strong relationships with regulatory agencies, industry associations, and key opinion leaders.
  • Lead and mentor the regulatory affairs team, fostering a culture of compliance and continuous improvement.
  • Contribute to the company’s strategic planning and decision-making processes as a member of the executive leadership team.


Qualifications:

  • Advanced degree in life sciences (PhD, PharmD, MD) or a related field.
  • A minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry, with a focus on oncology and autoimmune diseases.
  • Proven track record of successful regulatory submissions and approvals for cell therapy products.
  • In-depth knowledge of FDA, EMA, and other global regulatory requirements and guidelines.
  • Strong leadership and management skills, with experience building and leading high-performing teams.
  • Excellent communication, negotiation, and interpersonal skills.
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.
  • Strategic thinker with a strong attention to detail and a results-oriented approach.

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