Senior Regulatory Affairs Specialist
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.
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