What are the responsibilities and job description for the Vice President, Head of Regulatory Affairs position at MannKind Corporation?
Job Description:
The Vice President, Head of Regulatory Affairs will oversee the global strategy development and execution of regulatory affairs objectives. This position will be responsible for collaborating with clinical teams to develop and implement the US and global regulatory affairs plan across product portfolio.
This individual will provide strategic leadership and key insights that will allow the organization to operate collaboratively and proactively. They will interact closely with internal peers and externally with FDA, EMA, and other key stakeholders.
The ideal candidate will have a strong understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug promotional and development processes.
Key Responsibilities:
- Collaborate with Clinical Team to develop and implement the US and global regulatory affairs plan across product portfolio
- Oversee development and refinement of regulatory policies, procedures, and SOPs
- Provide regulatory assessments of product opportunities and threats
- Lead, develop, mentor and manage the Regulatory Affairs team
Education and Experience Qualifications:
- Bachelor's degree in a scientific discipline; Graduate degree (Ph.D. or PharmD) strongly preferred
- Progressive related experience in regulatory affairs in the pharmaceutical/biotech industry
Pay Range: $248,000 - $372,000 per year
Salary : $248,000 - $372,000
