What are the responsibilities and job description for the US Regulatory Strategy Lead position at Creative Solutions Services, LLC?
Job Description:
Creative Solutions Services, LLC is seeking a highly skilled US Regulatory Strategy Lead to join our team. In this role, you will play a crucial part in shaping our regulatory strategy and ensuring compliance with relevant laws and regulations.
About the Role:
This position offers the opportunity to substantially contribute to our mission by leveraging innovative science to create meaningful treatments for patients with cancer. You will work on cutting-edge assets, effectively liaising and negotiating with FDA, creating and implementing effective regulatory strategies, and preparing US regulatory submissions. Your responsibilities will include developing and implementing US regulatory strategies, strategizing and planning for FDA meetings, serving as the primary contact with FDA, and leading and preparing FDA submissions.
Key Responsibilities:
Qualifications:
To be successful in this role, you will need a BS degree in chemistry, biology, or a related scientific discipline and at least 10 years of experience in the pharmaceutical industry, with 8 years in regulatory affairs. You should have thorough knowledge of the IND and NDA/BLA processes, excellent oral and written communication skills, and strong interpersonal skills.
Creative Solutions Services, LLC is seeking a highly skilled US Regulatory Strategy Lead to join our team. In this role, you will play a crucial part in shaping our regulatory strategy and ensuring compliance with relevant laws and regulations.
About the Role:
This position offers the opportunity to substantially contribute to our mission by leveraging innovative science to create meaningful treatments for patients with cancer. You will work on cutting-edge assets, effectively liaising and negotiating with FDA, creating and implementing effective regulatory strategies, and preparing US regulatory submissions. Your responsibilities will include developing and implementing US regulatory strategies, strategizing and planning for FDA meetings, serving as the primary contact with FDA, and leading and preparing FDA submissions.
Key Responsibilities:
- Develop and implement US regulatory strategies for assigned projects.
- Strategize and plan for FDA meetings.
- Serve as the primary contact with FDA and liaison, negotiate, and orchestrate meetings and teleconferences.
- Lead and prepare FDA submissions, including briefing documents, breakthrough therapy designation requests, and orphan drug applications.
Qualifications:
To be successful in this role, you will need a BS degree in chemistry, biology, or a related scientific discipline and at least 10 years of experience in the pharmaceutical industry, with 8 years in regulatory affairs. You should have thorough knowledge of the IND and NDA/BLA processes, excellent oral and written communication skills, and strong interpersonal skills.
