In this role, you will lead development of all non-clinical, clinical, and commercial regulatory strategies including management of IND, NDA, and BLA submissions, FDA and other regulatory interactions, as well as international submissions. In addition, this role is responsible for building and managing regulatory operations and medical writing teams / consultants.
- Serve as global regulatory head and provide regulatory guidance and strategy, including identifying and assessing regulatory risks for non-clinical, clinical and commercial development plans and activities.
- Lead strategy and development of regulatory non-clinical, clinical submissions in conjunction with project teams.
- Assess regulatory project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time
- Oversee the preparation of meeting requests and briefing documents, and plan, execute and lead the coordination and preparation of teams for health authority meetings.
- Oversee compilation, electronic processing and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements.
- Serve as primary company representative to regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
- Advise senior leadership and project teams on status of US and global regulatory affairs strategies and tactics, procedures and practices and impact on the development and approval requirements.
- Oversee the maintenance and creation of relevant SOPs, Work Instructions and other necessary guidance.
- Support department budget and ensure operations are within the approved budget and timeline.
- Provide leadership and direction to staff, consultants, and vendors supporting regulatory affairs. Manage workload, train staff and effectively allocate resources.
Education and Experience Requirement
- Advanced degree, PharmD, or PhD preferred with a minimum of 10 years related experience
- Previous experience as regulatory head or lead for a product in clinical development
- Proven experience in developing strategies and submitting applications for small molecule or biologic products (INDs, NDAs, BLAs)
- Knowledge of global regulations and guidelines (nonclinical, clinical, labeling, promotional)
Other Job Requirements
- Positive attitude and willing to roll up her/his sleeves to get the job done; ability to pay close attention to detail and step back and think strategically
- Strong interpersonal verbal, written and presentation skills in communication with internal and external parties
- Nonstandard working hours and domestic / international travel will be required periodically