Clinical Regulatory Affairs Director

Clinical Regulatory Affairs Director

This role provides strategic leadership in clinical regulatory affairs for product development and registration. Responsibilities include overseeing regulatory compliance, managing documentation, and ensuring successful submissions to regulatory agencies worldwide.

Reports To: VP Regulatory Affairs (VP RA)

Key Responsibilities:

• Leads the clinical regulatory strategy for product development and registration.

• Provides expertise on regulations like FDA and EU for clinical development and submissions.

• Oversees clinical aspects of regulatory documentation.

• Manages interactions with regulatory agencies (e.g., FDA, EU) regarding clinical development.

• Supervises clinical regulatory affairs consultants.

Qualifications:

• Demonstrated leadership skills.

• Excellent interpersonal and communication skills.

• Proven project management experience.

• Deep understanding of clinical regulatory affairs, including FDA, EU, and other global regulations.

Education:

• Bachelor's degree in life sciences or a related field.

• Master's degree in regulatory affairs or a related field (preferred).

• Ten years of experience in clinical regulatory affairs within the pharmaceutical industry (CNS experience preferred).

Additional Information:

• Experience with combination drug-device products a plus.

• Fluency in written and spoken English required.

• Self-motivated and proactive work ethic essential.

• Experience in the global pharmaceutical industry preferred.