Associate Director of Regulatory Affairs

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Requirements:

• A minimum of 10 years in the pharmaceutical industry.
• A minimum of 8 years in Global Regulatory Affairs.
• Experience with major Health Authorities (US FDA, Health Canada, UK MHRA, EMA) is mandatory.
• Minimum of 6 years experience with regulatory submissions including INDs, NDAs, post marketing measures, pediatric submissions.
• Strong understanding of regulatory strategy and operational activities.
• Outstanding management, interpersonal, communication, negotiation, and problem-solving skills.

Responsibilities:

• Build relationships and collaborate in a global team environment for regulatory strategy management.
• Manage complex issues and coordinate multiple projects simultaneously.
• Create procedures for regulatory execution and support program leads.
• Collaborate with other functions to provide regulatory insight.
• Serve as point of contact with Health Authorities and lead interactions.
• Review regulatory guidelines and communicate impact assessments.