Regulatory Affairs Lead - Cell Therapy & Ocular Diseases
Seeking experienced Regulatory Affairs Lead to join a leading biopharmaceutical company with multiple potential blockbuster products in Clinical Trials.
*** Develop and implement regulatory development plans for drug products.
*** Act as point of contact with external regulatory authorities, agencies, investors, analysts, etc.
*** Ensure regulatory strategies and submissions comply with current regulations and standards.
*** Prepare, review, modify, approve, and submit regulatory documents such as IDEs (Investigational Device Exemptions), 51(k) Premarket Notifications, INDs (Investigational New Drug applications), PMAs (Premarket Approvals), CTAs (Clinical Trial Authorizations), NDAs, BLAs, etc.
*** Support design of clinical programs and trials for products from R&D to FDA approval.
*** Requires advanced degree (PhD or MD) in scientific discipline with 1+ years experience in Regulatory Affairs leadership.
*** Must have experience with, and understanding of regulatory requirements for Phase I-III drug development.
Excellent growth opportunities in a leading pharmaceutical company. Interaction with industry leading KOLs and executives with advancement potential into executive leaderhip. Perquisites include stock options, matched 41(k) and retirement plan. Full company paid medical, dental and health benefits with an industry leading compensation package and generous bonuses. Paid time off from the start, paid vacations and long term incentives.
Education Requirements: Doctorate degree
Minimum Experience Requirements: 1-15 years
Job City Location: Carlsbad
Job State Location: CA
Job Country Location: USA
Salary Range: $2, to $25,
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