Associate Director, Health Authorities
$185,000–$203,500 year
On-site · Summit, New Jersey, United States
Job Summary
The Associate Director, Health Authorities is responsible for advancing global clinical regulatory compliance for investigational and marketed products. Essential functions include managing the preparation of submission packages, leading Health Authorities direct reports, reviewing clinical data for compliance, and maintaining high-quality work products. Candidates should have expert knowledge of Health Authority guidance, strong leadership skills, and significant experience in clinical research and regulatory requirements. A Doctorate degree with relevant experience is required along with experience in staff management and regulatory submissions.
Required Qualifications
- Bachelor’s Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required
- Master’s Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required
- Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required
- Experience managing staff required
- Experience in the management and preparation of the submission of clinical modules in eCTD format required
- Experience in medical writing
- Experience with organizing responses to Health Authority information requests required
Desired Qualifications
- Experience with regulatory submissions outside of the US
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