Manager, Regulatory Affairs

Description

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. 
• We are Built by You. Your ideas influence the way we work, and your voice matters here. 
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. 

• Prepare submissions and oversee the maintenance of regulatory filings to support multinational trials (i.e., INDs, Clinical Trial Applications [CTAs], amendments, safety updates, and Annual Reports).
• Review clinical trial documents including clinical protocols/reports, investigator brochures and nonclinical reports.
• Assist in the preparation and review of regulatory filings to support U.S. and international marketing applications, applications under review by health agencies, and post-approval products (i.e., NDAs, supplements, Marketing Authorisation Applications [MAAs], variations, Annual Reports).
• Serve as the regulatory representative on project teams, manage regulatory timelines, and provide strategic input.
• Produce timely, scientifically accurate data summaries, ensuring documents are appropriate for inclusion in final reports and submissions to client and/or FDA. Construct documents in a manner consistent with applicable regulations and guidances and client strategic intent, conforming to Premier Consulting’s internal Standard Operating Procedures (SOPs).
• With some supervision lead global regulatory activities for pediatric investigation plans/pediatric study plans, Orphan Drug applications, Breakthrough Designation requests.

• Bachelor’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD preferred.
• 8+ years’ experience in a CRO, pharmaceutical, biotechnology or device/diagnostics industry, an advanced degree will be considered in lieu of a portion of industry experience.
• 5-6 years progressive regulatory affairs experience in a CRO, pharmaceutical, biotechnology, or device/diagnostics company.
• 2-3 years supervisory/management experience preferred.
• Knowledge of regulatory requirements, including ICH and FDA.
• Excellent organizational, writing (scientific and regulatory), communication, and time management skills needed to manage multiple ongoing projects simultaneously.

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.