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Boehringer Ingelheim · 2 days ago

AD, Regulatory Project Manager

Ridgefield, CT

Full-time

Onsite

Senior Level

$140K/yr - $222K/yr

5+ years exp

Boehringer Ingelheim is a global leader in the pharmaceutical industry, committed to improving the lives of patients and customers. The Associate Director, Regulatory Project Manager is responsible for delivering project management support to the Global Regulatory Lead and the Regulatory Excellence Team, focusing on regulatory strategy execution and project progress across the lifecycle of assigned projects.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Regulatory submissionsPharmaceutical industry knowledgeProject managementAdvanced project management certificationProject management softwareProactive problem-solvingCritical thinkingCommunicationOrganizational skillsMentorship mindset

Required

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

Preferred

Advanced certification in project management

Benefits

Role specific variable or performance based bonus

Other compensation elements

Company

Boehringer Ingelheim

Glassdoor4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees