Regulatory Project Manager (Global Submissions) - richmond hill

Regulatory Project Management - Support

Location: Remote

Job Type: Permanent/FTE

Position Overview:

As a Regulatory Project Manager, you will play a critical role in managing and coordinating global regulatory submissions, ensuring seamless collaboration across cross-functional teams. You will drive submission timelines, risk management strategies, and regulatory content planning to support successful product approvals.

Key Responsibilities - Primary Responsibilities

Submission Working Groups (SWGs)

Submission Management:

• Independently manage submissions and support internal RPM in handling initial major global filings.

• Co-lead SWGs with the designated regulatory lead for non-major global markets (MAAs and supplements).

Planning & Coordination:

• Work with functional sub-teams to develop submission timelines based on data availability and critical path activities.

• Identify and track critical paths, ensuring timely updates during the project lifecycle.

• Schedule and facilitate kick-off meetings with appropriate cross-functional representation.

Meeting Management:

• Prepare and distribute meeting agendas and materials in collaboration with the

GRL/EMRL or Regulatory Lead.

• Facilitate meetings, keeping the team on track and holding members accountable.

• Record and distribute meeting minutes, track action items, and maintain decision and risk logs.

Tracking & Documentation:

• Maintain submission timelines in project plans and ensure RPP updates as necessary.

• Identify potential resource constraints and escalate concerns to the GRL/Reg Lead.

• Maintain SWG InterACT site and distribute dashboards for SWG tracking.

Scenario Planning & Risk Management:

• Conduct scenario planning to identify potential risks and mitigation strategies.

• Attend functional sub-team meetings to track high-level submission timelines and risks.

• Ensure all submission documents are tracked and finalized within submission timelines.

Content & Regulatory Support:

• Collaborate with teams to create and maintain document/content plans.

• Support rapid response teams for agency questions, including authoring, reviewing, and approving responses.

• Assist with Advisory Committee preparations if necessary.

Regulatory Meetings & Documentation:

• Schedule and document regulatory meetings, including Meeting Request (MR) and Briefing Book (BB) preparations.

• Manage the authoring, review, and approval of regulatory-owned documents.

• Conduct lessons learned sessions and maintain logs for future improvements.

Secondary Responsibilities

Global Regulatory Teams (GRT)

Meeting Coordination:

• Schedule and facilitate GRT meetings, ensuring strategic and relevant agenda topics.

• Prepare and distribute meeting materials, collect team presentations, and send agendas in advance.

Meeting Facilitation & Documentation:

• Conduct meetings, track discussions, and ensure all decisions and risks are properly recorded.

• Follow up on action items and maintain decision logs.

• Escalate major risks to the GPT via InterACT.

Regulatory Project Plan (RPP) Management:

• Maintain and update RPP in InterACT, flagging major milestones and resource constraints.

• Ensure timely updates and alignment with project goals.

Regulatory Support & Team Engagement:

• Maintain GRT InterACT site, roster, distribution lists, and notification emails.

• Partner with GRL to draft and update regulatory presentations and reports.

• Monitor progress on goals and ensure periodic team health checks.

Agency Meeting Logistics & Global Regulatory Planning (GRP):

• Arrange logistics for agency meetings if requested.

• Initiate creation/revision of GRP per GRT Charter schedule and track progress.

Interactions with Internal Teams & Stakeholders:

• Lead RPM

• GRL

• Functional Leads (Clinical, Medical Writing, Safety, CMC, Publishing, Ops Support)