AD, Regulatory Project Manager

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Associate Director, Regulatory Project Manager manages the execution of critical regulatory project deliverables by coordinating activities across Global Regulatory Affairs and cross-functional stakeholders. This includes managing the internal Regulatory Excellence Team (RET) to drive regulatory readiness and alignment within GRA, as well as managing the cross-functional Submission Deliverable Team (SDT) to coordinate planning and execution of complex regulatory submissions. Through strong facilitation, stakeholder management, and governance, you will ensure accountability, effective decision-making, and timely delivery of key regulatory milestones.

The Associate Director, Regulatory Project Manager creates and updates critical path for submission, including internal and external events. Ensures delivery of E2E submissions, track key submission metrics (milestones, timelines, resourcing, documentation) and support / coordinate the submission team in Regulatory, relevant cross-functional stakeholders and beyond. The incumbent coordinates the interactions with all key stakeholders, both internal and external as well as supports the RET in the project coordination, meeting set-up, documentation and tracking of actions. This role liaises with the brand team program manager to coordinate regulatory input and interactions into the overall asset strategy / Evidence Network.

The Associate Director, Regulatory Project Manager inspires the team to embrace agile ways of working so to maximize speed and effectively execute the regulatory strategy.

Duties & Responsibilities

• Accountable for translating regulatory strategy into actionable plans.
• Accountable for tracking and reporting of key project metrics (milestones, timelines, resourcing, documentation, seamless execution, KPIs) for assigned projects.
• Responsible for the seamless execution of project deliverables and related activities; escalates delays to GRL and respective teams.
• Holds team accountable to project plan and their commitments.
• Organizes necessary follow ups and deployment of necessary knowledge and resources.
• Responsible for proper project documentation, e.g., of regulatory strategy, key decisions and roadmap.
• Ensures the information is up-to-date and consistent.
• Tracks regulatory actions and deliverables from pre-IND (Investigational New Drug) to Marketing Authorization Application (MAA) submission, including Health Authority (HA) interactions, Clinical Trial Application (CTA) submissions, Development Safety Update Report (DSURs), etc.
• In collaboration with the GRSL, creates and manages regulatory project plan including timelines and interdependencies.
• Creates and updates critical path for submission, including internal and external events.
• Ensures delivery of E2E submissions (MAAs), track key submission metrics (milestones, timelines, resourcing, documentation, submission rollout, approvals and HA feedback) and support / coordinate the submission team in Regulatory, cross-functional stakeholders and beyond. Coordinates with Asset & Evidence teams to gather necessary data, documents, and information required for submission, ensuring the timely and accurate compilation of regulatory documents.
• Institutes operational excellence and consistent execution and coordination of RET activities.
• Ensures proactive identification of risks, backlogs, deviations and compliance topics, working with team members in their respective areas, and brings them together to develop recommendations and risk mitigation plans.
• Ensures generation, coordination and RA input to key development, registration and commercialization documents for assigned projects (e.g., development plans, protocols, clinical trial reports, CTAs, pediatric development plans and applications, core dossier elements, integrated brand plans, market access documents, with particular emphasis to company’s overall hyperfocus and focus country prioritization).
• Sets up effective team communication channels, meetings and meeting agendas, takes and circulates minutes, ensu