Senior Regulatory Affairs Specialist (PR/613523) Summit, New Jersey
An innovative commercial-stage biotechnology company is seeking a Senior Regulatory Affairs Specialist to support regulatory compliance and submission activities across both marketed products and development-stage programs. This individual will contribute to regulatory strategy, health authority interactions, and global submission activities while partnering closely with cross-functional teams in a fast-paced environment.
Responsibilities:
Serve as a Regulatory Affairs subject matter expert across the organization.
Prepare, review, and approve CTDs and other regulatory submissions for compliance and technical accuracy.
Support U.S. and global regulatory strategies for development and commercial products.
Coordinate responses to health authority requests and inquiries.
Monitor regulatory guidance, requirements, and industry trends.
Author and review Regulatory Affairs SOPs and related documentation.
Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
Qualifications:
Bachelor's degree with 7+ years or Master's degree with 5+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
Experience supporting regulatory submissions and health authority interactions.
Strong knowledge of FDA, ICH, and global regulatory requirements.
Experience preparing responses to regulatory agency questions and requests.
Excellent project management, communication, and organizational skills.
Ability to manage multiple priorities and work effectively in a collaborative environment.
