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 regulatory submissions.
- Responsible for ensuring positive and proactive communications with the Leadership Team and Development Teams keeping them informed of regulatory statuses and significant regulatory issues, communicating risks and ensuring mitigations/contingencies.
- Able to oversee all project related regulatory strategy with all global project teams.
- Assure compliance with project team timelines and milestones for global regulatory deliverables.
