Director/Senior Director – CMC Regulatory Affairs

Director/Senior Director – CMC Regulatory Affairs

Requirements

• Bachelor’s Degree in a relevant scientific discipline, advanced degree preferred.
• Minimum 8 years of relevant experience in CMC Regulatory Affairs.
• Experience in biologics drug development and license applications.
• Demonstrated track record of successful submissions to FDA and/or other health authorities.
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
• Excellent interpersonal, verbal, and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Responsibilities

• Leads the development and implementation of CMC regulatory strategy for programs in early-/mid- development stage, in preparation of licensure.
• Actively seeks out regulatory knowledge and incorporates this knowledge into submission planning and execution. Stays current with regulatory requirements.
• Proactively identifies regulatory risks and regulatory opportunities.
• Contributes to the appropriate execution of CMC regulatory strategy, including authoring regulatory documents (e.g. IND/BLA sections and meeting packages).
• Operates with effectiveness across functions.
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Ensures CMC dossiers meet format and content requirements, as well as specific local requirements of individual countries.
• Analyzes and exercises judgment on complex issues, guided by a thorough understanding of CMC.

Preferred Qualifications

• Advanced degree preferred.