Associate Manager, Regulatory Operations ()

We are looking for an Associate Manager, Regulatory Project Manager to provide regulatory project management support across a growing portfolio. This role is part of the Global Regulatory Project Management function and supports regulatory submissions including NDAs, BLAs, INDs, CTAs, and other regional filings. The ideal candidate will coordinate regulatory strategies, timelines, and deliverables while ensuring alignment with corporate goals.
 

• Collaborate with cross-functional teams to develop and execute regulatory strategies and submission plans, focusing on regulatory filings for Rest of World (RoW) regions.

• Create and manage high-level and detailed regulatory timelines using project management software, ensuring alignment with corporate objectives.

• Facilitate regulatory team and working group meetings, including scheduling, preparing agendas, distributing documentation, and ensuring action item follow-up.

• Coordinate and track regulatory documents for submissions, ensuring compliance with ICH guidelines, regional requirements, and company policies.

• Maintain transparent and timely communication about submission-related activities, keeping all stakeholders informed of progress and status.

• Proactively identify and address potential issues that could impact project timelines or deliverables.

• Support the development and continuous improvement of regulatory business processes, tools, templates, dashboards, and project management practices.
   

• Bachelor’s or higher degree in a related field with at least 4 years of experience in the biopharmaceutical industry, preferably in regulatory project management or a related discipline.

• PMP or similar project management certification is preferred.

• Working knowledge of drug development processes and regulatory agency regulations, guidelines, and submissions.

• Proficiency in project management tools such as Microsoft Project and Smartsheet, as well as the MS Office suite.

• Demonstrated ability to manage multiple tasks, prioritize effectively, and meet deadlines.

• Strong verbal and written communication skills, attention to detail, and the ability to collaborate effectively in a team environment.

• Self-motivated and capable of working independently within a matrix organization.

Department: Direct Clients
This is a full time position