Senior Manager Regulatory Project Management

@ Alnylam Pharmaceuticals

Overview

The Senior Manager Regulatory Project Management at Alnylam Pharmaceuticals leads regulatory-focused project management activities across the R&D product lifecycle including global expansion.

Key Responsibilities

Develop and continuously optimize detailed regulatory project plans and timelines in collaboration with the Global Regulatory Lead, Regulatory Operations, and sub-team leads. Identify and manage project interdependencies and track key submissions/deliverables from investigational and marketing applications to registration.

• Interface with filing sub-teams to ensure mutual understanding on timelines and deliverables.
• Plan and facilitate cross-functional meetings/workshops to drive submission strategies.
• Co-lead critical filing meetings ensuring follow-through on deliverables and action items.
• Develop document reviewer/approver matrices and coordinate review cycles.
• Maintain project dashboards to communicate progress, risks, and updates.
• Identify and escalate risks related to resources, timing, and deliverables.
• Coordinate lessons learned sessions to implement process improvements.
• Contribute to best practices and standardized processes for regulatory submissions.

Requirements

Bachelor's degree in life sciences, pharmacy, or related field preferred with at least 6 years' experience in regulatory affairs or project management within the pharmaceutical or biotech industry. Proven project management skills, strong prioritization, and excellent written and verbal communication skills are essential. Familiarity with project management tools (e.g., Smartsheet, MS Project) and timeline visual tools (e.g., OnePager, Think-Cell) is a plus.

Key skills/competency

Regulatory, Project Management, Global Submissions, R&D, Timeline Management, Cross-functional, Communication, Facilitation, Risk Management, Process Improvement