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

Major tasks and responsibilities include:

• Leads and contributes to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.
• Provides leadership for the development of the CMC regulatory strategy for global submissions.
• Develops and manages CMC submission documents, registration dossiers, and responses to health authorities.
• Is responsible for the regulatory evaluation of CMC change controls.
• Represents Regulatory CMC on Regulatory Affairs team.
• Interacts with regulatory agencies and 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 preferred.
• A minimum of 8 years of CMC regulatory experience is required.
• Must have demonstrated record of accomplishments in the life sciences industry.
• Must have experience in preparing CMC regulatory documents.
• Must have strong leadership in working with multiple functional areas.
• Must be detail oriented with strong verbal and written communication skills.
• Knowledge of GxP, ICH, FDA, EMA and other global regulations is required.
• Must have experience leading regulatory CMC strategy for biologics development programs.
• Requires teamwork skills and commitment to competing with a high 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.