Vice President, Global Regulatory Affairs

Remote, Worldwide

This individual will have accountability for the global regulatory department and will lead a team of highly qualified regulatory professionals in oversight and management of key regulatory functions including global regulatory operations, strategy, labeling, and medical writing.

Essential Duties and Responsibilities

Accountable to lead the global regulatory strategy for the Company’s products (approved and pipeline).

Provide counsel, training, and interpretation of global regulatory authorities’ feedback, policies and guidelines.

Have oversight and accountability of the Company’s interactions with global regulatory authorities.

Interpret, plan, and communicate requirements to ensure global marketing applications

Oversight and accountability for medical writing and global regulatory operations.

Ensure Investigative New Drug Applications and global clinical trial applications are cleared/approved.

Lead and represent the Company before regulatory authorities together with regulatory professionals and subject matter experts.

Interact with other functions, leaders and project teams in the preparation, review, and completion of global regulatory strategies and documents for...