Associate Director, Regulatory Affairs - Combination Products - Remote

Overview

The Associate Director, Regulatory Affairs will join our team and play a key role in providing both technical and managerial leadership to principal, senior, and associate level resources through both direct and indirect reporting structure. This role will also be responsible for leading regulatory service projects by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory applications for drug products, biologics, medical devices, and combination products.

In Short

• Provide leadership to external-facing Kymanox project teams.
• Lead planning and execution of regulatory activities.
• Prepare regulatory applications for regulatory authorities.
• Review and edit dossiers and responses to regulatory authority questions.
• Manage regulatory application timelines according to client expectations.
• Work directly with eCTD publishing resources.
• Perform due diligence reviews and inform executive counsel/investors of regulatory risks.
• Provide mentorship and development opportunities to the regulatory team.
• Support internal business initiatives to improve Kymanox processes.
• Ensure conformance to Kymanox quality and external regulatory compliance standards.

Requirements

• 10+ years of regulatory experience in pharmaceuticals, biologics, and combination products.
• 5+ years in a Regulatory Affairs leadership role managing direct reports.
• Recognized subject matter expert for regulatory strategy.
• Successful track record of product approvals in different global markets.
• Demonstrated experience preparing regulatory applications for clinical and marketing authorization.
• Working knowledge of relevant standards and guidance documents.
• Detail-oriented with strong organizational skills.
• Ability to form partnerships with internal and external stakeholders.
• Technology savvy.
• Up to 20% travel may be required.

Benefits

• Medical healthcare including dental and vision.
• Short- and long-term disability.
• Life insurance.
• Matching 401(k) retirement plan.
• Continuing education assistance.
• Incentive program after 90 days of outstanding work.