Principal Regulatory Affairs Specialist

Join Us as a – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to serve as the lead over several countries / projects in providing innovative solutions, including regulatory expertise and client interface. As a Principal Regulatory Affairs Specialist , you'll provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization with a major focus on life cycle management activities. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.

What You’ll Do :

• Creates draft documents of module 1 and provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services.
• Provides matrix / project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and / or project deliverables.
• May provide input on peformance reviews to management.
• Ensures adherence to project budgets, time schedules, and scope of work.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Contributes to business development activities, including project budgeting / forecasting.

Education and Experience Requirements :

Knowledge, Skills and Abilities :

Working Conditions and Environment :