Position Details
About this role
This role involves leading regulatory affairs for radiopharmaceuticals in early development, including strategy, submissions, and interactions with regulators. The candidate will oversee clinical and nonclinical regulatory functions within a biotech setting.
Key Responsibilities
- Develop regulatory strategies
- Manage regulatory filings
- Lead interactions with regulators
- Author regulatory documents
- Oversee clinical and nonclinical regulatory activities
Technical Overview
The role requires expertise in regulatory strategy for oncology and radiopharmaceuticals, experience with IND and other regulatory filings, and leadership in a biotech environment.
Ideal Candidate
The ideal candidate is a senior regulatory professional with over 10 years of experience in clinical and nonclinical regulatory strategies, particularly in oncology and radiopharmaceuticals. They possess strong leadership skills and a proven track record in managing regulatory submissions and interactions with health authorities.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 10 years regulatory experience, Lack of oncology or radiopharmaceuticals background, No experience with regulatory filings, Inability to work remotely
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