Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is a pharmaceutical company focused on the discovery, development, and delivery of products to patients and customers. The Associate Director, Regulatory Project Manager translates regulatory strategy into actionable plans, coordinates regulatory submissions and cross-functional teams, tracks project milestones, and drives regulatory readiness and agile execution.
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, ensures actions are logged, tracked and acted upon
- Ensures alignment within the RET and orchestrates team to develop cohesive input
- Maintains repository of presentations and decisions
- Communicates key decisions to accountable stakeholders outside the RET if applicable
- Supports GRL in the setup, coordination and preparation of important internal and external meetings, e.g., Health Authority interactions and senior leadership updates and committees
- Maintains repository of key project documents and logs, including information on HA interactions, partners and collaborators
- Supports GRL in coordination with local RA colleagues, maintaining repository of key inputs, questions and HA interactions
- Relentlessly drives prioritization, efficiency and speed and facilitates team's agile ways of working (i.e., sprint planning, daily stand-ups, retrospectives etc.)
- Liaises with the asset team program manager to coordinate regulatory input and interactions into the overall asset strategy / Evidence Network
- Sets up and coordinates cross-functional problem-solving as necessary
- Serves at operational level critical interfaces such as the Asset & Evidence Team and manages communication channels to keep stakeholders informed about regulatory developments, changes, and approvals
- Provides regular updates on regulatory milestones and their impact on the overall project timeline
Skills
- Minimum requirement: Bachelor's degree in a relevant field, such as life sciences, pharmacy, chemistry, or Business Administration with five (5) years of progressive experience in the pharmaceutical or biotechnology industry, with a focus on project management
- Significant experience in managing complex projects and cross-functional teams
- Experience in project management, preferably within the Pharmaceutical or Biotech industry
- Demonstrated understanding and application of broad portfolio of project management processes and tools, including database handling and tracking tools
- Knowledge of pharmaceutical industry and experience in collaborating with related core and enabling functions
- Familiarity with project management software (like Microsoft Project, Asana, etc.) and pharmaceutical industry-specific software
- Critical thinking with the ability to influence, negotiate and manage conflicts at all levels to achieve team alignment, commitment to deliverables with positive team environment
- Strong communication skills, ability to present complex relationships in a concise and structured manner
- Proactive, strives to develop solutions and promote their acceptance
- Experience in how to create and nurture a psychologically safe, try-and-learn work environment while keeping ambitious timelines
- Finding opportunities for standardization across projects based on interaction with peer project managers
- Act as task master, support GRSLs and RET in resolving issues quickly
- Expert knowledge of agile principles and practices
- Strong organizational skills, managing timelines effectively and flexibly if challenges arise
- Strong mentorship and apprenticeship mindset to foster a culture of continuous learning and development
- Must be legally authorized to work in the United States without restriction
- Must be 18 years of age or older
- Preferred: Advanced certification in project management
- Knowledge of regulatory aspects and submissions is an advantage
- Regulatory and relevant Therapeutic area expertise is advantageous
Company Overview