Project Manager– Regulatory Affairs

AI overview

Drive the success of long-term regulatory projects by coordinating teams, managing documentation, and providing strategic guidance to meet project milestones.

JOB DESCRIPTION


Job Title

Project Manager– Regulatory Affairs

 

Department

Regulatory Affairs

Responsibilities

 

·       Assist in the planning and tracking of long-term regulatory projects and submission timelines.

·       Regularly communicate with clients to understand their needs and proactively address them.

·       Coordinate cross-functional team meetings and facilitate communication to ensure project milestones are met.

·       Maintain accurate project documentation including project plans, timelines, and status reports.

·       Drive regulatory updates and assist in assessing their impact on ongoing projects.

·       Contribute to the development and improvement of regulatory project management processes and tools.

·       Track project deliverables and resource utilization using appropriate tracking tools to provide direction and support to the project team.

·       Identify and escalate issues and potential issues in a timely manner to ensure efficient resolution

·       Provide independent advice on the management of projects based on lessons learned and gained experience.

·       Contribute to the preparation of RFI/RFPs/defense bid and act as a guide to the sales and business development team.

Skills and Qualifications

·       Having experience in managing regulatory operations projects as PM

·       Strong English communication is a must

·       Self-driven individual

·       Flexible to travel for long durations – to Armenia

·       Mid-level experience 8-10 years should be fine

 

 

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!  

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