Sr. Director, Clinical Regulatory Affairs
$178k-236k (estimate)
Full Time
1 Week Ago
ClinCrowd is Hiring a Sr. Director, Clinical Regulatory Affairs Near Waltham, MA
- Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required
- Experience supporting clinical development teams in the autoimmune disease space is a must
- Provides regulatory guidance and input to project teams
- Designs and implements regulatory strategies to obtain and maintain clinical trial applications
- Oversees the creation and submission of all regulatory filings
- Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
- Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals
- Experience in Oncology and Immuno-oncology is preferred but not required
- Arranges for and leads meetings with global health authorities as needed
- Provides training and mentorship to regulatory staff and other junior staff at the company
Job Summary
JOB TYPE
Full Time
SALARY
$178k-236k (estimate)
POST DATE
05/01/2024
EXPIRATION DATE
05/14/2024
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