pfm medical, inc. is hiring a
Senior Director of Regulatory Affairs in United States

Summary

The Senior Director of Regulatory Affairs will provide strategic, technical, and regulatory guidance for clinical development and drug development life cycles. They will lead regulatory consulting services and maintain technical knowledge in product development and international regulatory affairs. The role involves providing high-quality regulatory advice and development strategies for clients across various therapeutic indications and leading teams during major filing activities and Health Authority interactions.

Requirements

• 12+ years or more relevant regulatory affairs experience
• Comprehensive understanding of financial management
• Expertise in all aspects of the drug development process, including regulatory milestones and clinical trials methodology
• Specialized knowledge of regulatory activities such as submissions to regulatory authorities (INDs/CTAs and amendments, ODDs, and PIPs)
• Understanding and communication of regulatory requirements for pharmaceutical development submissions during the life cycle of a product
• Experience in pharmaceutical product development and marketing authorizations (MAA/CTAs/INDS/NDA and or BLA/sBLA) experience in filings in an eCTD format
• Post Graduate Degree, bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline
• Experience in functional management including experience in delegating while fostering cohesive team dynamics
• Computer literacy in MS Office/ Office 365
• Availability for domestic and international travel including overnight stays

Responsibilities

• Provide strategic, technical, and regulatory guidance for clinical development and drug development life cycles
• Lead regulatory consulting services and maintain technical knowledge in product development and international regulatory affairs
• Provide regulatory strategy and leadership for all North America and/or International (inc. European) regulatory submissions
• Support the further development of the Regulatory department and enhance corporate Regulatory functions

Benefits

• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation