[Remote] AD, Regulatory Project Manager

Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is a global leader in the pharmaceutical industry, dedicated to the discovery, development, and delivery of innovative products. The Associate Director, Regulatory Project Manager will provide project management support for regulatory strategy execution, ensuring timely delivery of submissions and coordination among cross-functional teams. 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 GRL, 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 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 • Knowledge of regulatory aspects and submissions is an advantage • 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 • Regulatory and relevant Therapeutic area expertise is advantageous • 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 GRLs 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 willing to take a drug test and post-offer physical (if required) • Must be 18 years of age or older • Advanced certification in project management Benefits • Role specific variable or performance based bonus • Other compensation elements Company Overview • Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim. It was founded in 1885, and is headquartered in Ingelheim Am Rhein, Rheinland-Pfalz, DEU, with a workforce of 10001+ employees. Its website is Apply tot his job