Senior Regulatory Affairs Consultant – Senior Regulatory Project Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Collaborate strategically with Global Regulatory Leads to develop and implement regulatory plans that are aligned globally throughout both development and post-marketing stages.

• Convert regulatory strategies into actionable plans that include milestones, critical paths, risks, and opportunities.

• Oversee the execution of regulatory plans across international programs.

• Discover innovative regulatory pathways and planning scenarios.

• Work alongside cross-functional teams and senior leadership on regulatory deliverables, timelines, and interdependencies.

• Organize Global Regulatory Subteam meetings and project review forums.

• Create meeting agendas, set objectives, maintain action logs, document decisions, track follow-up items, and manage meeting materials.

• Ensure governance of GRST, maintain meeting frequency, align stakeholders, and facilitate communication across global and regional teams.

• Anticipate and resolve complex regulatory project and operational challenges.

• Prepare strategic dashboards, reports, and scenario plans for senior stakeholders.

• Transform regulatory progress and risks into actionable business insights.

⛳️ Requirements

• A BA/BS degree in a scientific, engineering, or healthcare discipline is required.

• At least 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences sector.

• A minimum of 5 years in regulatory affairs or regulatory program management.

• Experience in product development, including IND/BLA/MAA submissions, global registrations, and post-marketing activities.

• Previous experience with marketing applications is essential.

• A comprehensive understanding of U.S. and EU regulatory requirements along with working knowledge of global regulations and agency expectations.

• Proven experience managing complex regulatory deliverables across cross-functional teams in a matrix organization.

• Practical experience with eCTD and regulatory documentation, including formatting and submission strategies.

• Experience in supporting global development programs across various modalities or therapeutic areas is preferable.

• Outstanding communication and influencing skills.

• Strong judgment and agility in managing competing priorities, resource limitations, and changing program needs.

• Proficient in using project management tools and best practices to enhance visibility, efficiency, alignment, and meeting outcomes.

• Experience in facilitating cross-functional meetings, driving structured agendas, documenting decisions and actions, and ensuring team accountability.

• Dedicated to continuous learning and improvement with an innovation-oriented mindset.

• Expert proficiency in Smartsheet and the Microsoft Office Suite.

• Skilled in creating visuals with PowerPoint derived from timeline integration tools like One Pager and Office Timeline Pro.

• Proficient in using Veeva Regulatory Information Management (RIM).

🏝️ Benefits

• Opportunity to work from home.

• Chance to influence global regulatory strategy and contribute to groundbreaking scientific advancements.

• Engage in the development of transformative vaccines and therapies that enhance patient outcomes worldwide.

• Commitment to continuous learning and improvement.

• Innovation-driven workplace environment.