Sr. Regulatory Affairs Consultant
Responsibilities of the Sr. Regulatory Affairs Consultant:
- Supports the development of global regulatory strategy for all assigned R&D and marketed project(s).
- Provide strategic and operational regulatory services to support ongoing US and global development and commercialization activities.
- Provide support for ex-US regulatory interactions, including orphan drug applications and MAA planning.
- Assist in the development and integration of regulatory and quality assurance processes for GXP compliance, including writing SOPs, document development, and archives.
- Ensure operations are compliant with FDA, ICH, EMA and industry standards.
- Authors, coordinates (including TOC/submission trackers), reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs within company timelines and in accordance with regulations and guidelines.
- Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.
Requirements of the Sr. Regulatory Affairs Consultant:
- MS or PhD with 10+ years regulatory experience within biotech and/or pharma.
- Excellent working knowledge of drug development process and up-to-date knowledge of FDA regulatory requirements, regulations and guidelines.
- Strong familiarity with the global regulatory environment.
- Paid time off
- Medical and dental insurance
- 401K Match
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.