Our client is a late-stage biotechnology company. They have asked us to assist them in a search for a Director, CMC Regulatory.  

Major tasks and responsibilities include:

• Manages and contributes to regulatory strategies that leads to expedited development, higher probability of success, and mitigated risks.
• Leads the development of the CMC regulatory strategy for global submissions.
• Develops and manages the content and preparation of CMC submission documents.
• Manages responses to health authorities.
• Is responsible for the regulatory evaluation of CMC change controls.
• Represents Regulatory CMC on CMC development and Regulatory Affairs teams.
• Represents CMC at regulatory agency meetings.

We seek candidates with the following qualifications:

• A Bachelor’s degree in a scientific discipline is required. A Master’s degree or higher is preferred.
• Must have eight to ten years of experience including at least eight years of CMC regulatory experience.
• Must have demonstrated record of accomplishments in the life sciences industry expanding from a clinical stage company through to commercialization.
• Leadership in preparing CMC regulatory documents is required.
• Must have strong leadership in working with multiple functional areas in a fast-paced matrixed team environment.
• Requires strong verbal and written communication skills with exceptional attention to detail. Must be able to articulate analytical and regulatory viewpoints to internal and external audiences.
• Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidances is required.
• Experience leading regulatory CMC strategy and input for biologics development programs is required.
• Must have strong teamwork skills and a commitment to competing with the highest level of integrity in a remote working environment.

 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.