For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.We do things differently than large CROs and would love to have you join our Veristat team!The Senior Regulatory Affairs Specialist will independently lead simple to moderate regulatory programs to success and is responsible for assisting with all consulting assignments and client deliverables from Veristat Regulatory staff. The Senior Specialist will provide consult to clients independently and work with Regulatory leaders to solve challenging client questions. S/he will serve on project teams, provide advice on regulatory agency interactions, support the preparation of submissions, and create strong rapport with clients. The Senior Regulatory Affairs Strategist may begin to work on projects of increasing complexity with oversight from senior Regulatory team members and management.

As a Senior Regulatory Affairs Specialist You Will...

• Provide consulting services in regulatory program strategy, overall drug development plans, and strategic regulatory communications, independently for simple to moderate programs, and will begin to take on increasingly complex assignments with oversight from Regulatory leaders.
• Oversee the Regulatory Affairs aspects of assigned client projects and project teams through the coordination of internal staff and third-party vendors.
• Write, review, and provide strategic regulatory guidance on alternative pathways, such as fast track, breakthrough (and other expedited programs), orphan, and 505(b)(2), and corresponding pathways in Europe (in collaboration with EU strategist/consultant).
• Prepare clients for FDA meetings, and as contracted, serve as authorized regulatory representative, with oversight from Regulatory leaders.
• Provide strategic and regulatory compliance reviews of documents for marketed products, including marketing materials, Field Alert Reports, Individual Case Safety Reports, and Periodic Safety Updates.
• Prepare and present at internal and client meetings as needed to provide regulatory guidance.
• Provide a high standard of customer service and ensure complete understanding of Veristat’s offerings and responsibilities.
• Works with Regulatory Affairs staff to ensure the timely submission of client regulatory documents, including pre-IND submissions, INDs, marketing applications, etc.

• Assists the Head of Regulatory with internal regulatory intelligence activities.
• Strives to consistently uphold Veristat core values.

Experience & Minimum Requirements:

• Bachelor’s degree in life/health sciences or related discipline, or equivalent required.
• 5 years of regulatory consulting and project management experience in a CRO or pharmaceutical company required. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by casebasis.
• Knowledge of International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Demonstrated ability to develop and foster positive client relationships.
• Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
• Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.#LI-Remote