Regulatory Affairs Strategy Manager (Oncology)

Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies.

Requirements

• Review clinical site regulatory documents to provide Regulatory approval to ship investigational product.
• Track safety reports and coordinate submissions to US INDs.
• Assist Project Team Regulatory Representative in preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence.
• Assist with developing and implementing strategies to ensure compliance with HA requirements.
• Respond to requests for information from regulatory bodies.
• Serve as liaison with FDA.
• Work collaboratively with consultants and contractors to accomplish regulatory activities and submissions.
• Contribute to department initiatives.

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in first year
• 17 paid holidays
• 10 sick days