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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Seniority level
Director
Employment type
Full-time
Job function
Legal
Industries
Internet Publishing
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