Description: Our client is currently seeking a Director, US Regulatory Affairs
The Director, US Regulatory Affairs is responsible for providing strategic leadership and oversight of all U.S. regulatory activities for assigned products. This role is responsible for ensuring compliance with FDA regulations and guidelines driving regulatory strategies and facilitating successful interactions with regulatory authorities. Additionally, this role provides strategic regulatory guidance and support to our global programs, with a specific focus on US regulatory requirements.
RESPONSIBILITIES
Direct and coordinate activities of assigned products within Regulatory Affairs encompassing developmental products and post-marketing commitments.
Function as the primary contact for negotiations and interactions with the FDA and offer guidance and strategy to ex-US strategy and filings.
Contribute to developing regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications.
MINIMUM JOB REQUIREMENTS
Bachelor's degree in a scientific discipline (advanced degree preferred).
Minimum of 10 years' experience in US Regulatory Affairs within the pharmaceutical or biotechnology industry. Direct CDER experience preferred. RAC certification preferred.
Possess a deep understanding of FDA/ICH regulations, guidelines, and regulatory processes across various product types (i.e .drugs, biologics) and ex-US requirements ensuring ongoing compliance with FDA/ICH regulations, guidelines and current Good Manufacturing Processes (cGMP).
Adept at establishing processes and systems to drive regulatory requirements throughout the lifecycle.
Demonstrated proficiency in preparing, reviewing, and submitting regulatory filings to the FDA, including INDs, NDAs, BLAs, and other relevant submissions ensuring accuracy, completeness, and timeliness of submissions.
Contact: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
