Senior Director or Vice President of Regulatory Affairs

Company Overview:

Based in San Diego, CA, our client is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Join our dynamic team and be part of the transformative journey!

Position Overview:

We are in search of an accomplished and dynamic Senior Director of Regulatory Affairs to join our team. This pivotal role will spearhead regulatory strategies and activities concerning the development and approval of cell therapy products. Reporting directly to the Chief Medical Officer, the Senior Director will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives.

Key Responsibilities:

• Lead strategic planning and execution of clinical regulatory strategies, agency interactions, and submissions
• Collaborate with the Executive team to define regulatory strategies for both internal and partnership programs
• -Oversee the compilation, review, and submission of regulatory interactions with agencies, ensuring accuracy, completeness, and timeliness
• Provide guidance on Regulatory CMC strategy and support development teams in interpreting and applying regulations and guidance documents
• Offer strategic and regulatory compliance input to protocols, reports, and other source documents
• Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project teams
• Lead regulatory meetings with agencies and develop briefing packages for such engagements
• Collaborate with cross-functional teams and support functions, including full-time staff and independent consultants, as required
  
  

Qualifications:

• Minimum of 10 years of experience in Clinical Regulatory Affairs within drug development
• Advanced degree in a scientific discipline is mandatory
• Extensive hands-on regulatory experience leading Clinical, Nonclinical, and CMC strategy and documentation
• Proven track record of developing regulatory submissions in the biotechnology sector, preferably in cell therapy
• Strong knowledge of FDA and EMA regulations
• Experience with mechanisms to expedite agency interactions, such as Fast-Track and Breakthrough Designation
• Excellent communication skills with the ability to influence stakeholders internally and externally
• Self-motivated, with the ability to work independently or as part of a team
• Strategic thinker with strong problem-solving skills
• Exceptional organizational skills with the ability to prioritize tasks in a fast-paced environment
  
  

Physical Requirements:

• Ability to communicate verbally and in writing effectively
• Regular use of office equipment such as computers and workstations
• Occasional lifting or moving of up to 10 pounds may be required
  
  

Work Environment:

• Work primarily in an office environment with occasional work in or around laboratory settings
• This position requires 100% on-site work at our corporate headquarters in San Diego, CA
• Flexibility for evening and weekend work as necessary
  
  

This job description offers an opportunity for seasoned regulatory professionals to contribute significantly to groundbreaking advancements in cell therapy.

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