Boehringer Ingelheim
AD, Regulatory Project Manager
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AD, Regulatory Project Manager
role at
Boehringer Ingelheim
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Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to patients and customers. Our global presence provides opportunities for international collaboration, offering visibility and the chance to directly contribute to the company’s 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.
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 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), tracks key submission metrics (milestones, timelines, resourcing, documentation, submission rollout, approvals and HA feedback) and supports / coordinates the submission team in regulatory and cross‑functional stakeholders. Coordinates with Asset & Evidence teams to gather necessary data, documents, and information for submission, ensuring 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 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
Requirements
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
Preferred: Advanced certification in project management
Technical skills
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
Soft skills
Critical thinking with the ability to influence, negotiate and manage conflicts at all levels to achieve team alignment and commitment to deliverables with a 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 creating and nurturing 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
Eligibility Requirements
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
Additional Duties & Responsibilities
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 the 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
Compensation This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role‑specific variable or performance‑based bonus and/or other compensation elements. For an overview of our benefits please click
here .
Our Company Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths—and break new ground in the drive to make millions of lives better. Here, your development is our priority. We support you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after—as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you’ll be helping to transform lives for generations.
Want to learn more?
Visit our website
Seniority level: Mid‑Senior level | Employment type: Full‑time | Job function: Project Management and Information Technology | Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr
AD, Regulatory Project Manager
role at
Boehringer Ingelheim
Get AI-powered advice on this job and more exclusive features.
Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to patients and customers. Our global presence provides opportunities for international collaboration, offering visibility and the chance to directly contribute to the company’s 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.
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 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), tracks key submission metrics (milestones, timelines, resourcing, documentation, submission rollout, approvals and HA feedback) and supports / coordinates the submission team in regulatory and cross‑functional stakeholders. Coordinates with Asset & Evidence teams to gather necessary data, documents, and information for submission, ensuring 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 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
Requirements
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
Preferred: Advanced certification in project management
Technical skills
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
Soft skills
Critical thinking with the ability to influence, negotiate and manage conflicts at all levels to achieve team alignment and commitment to deliverables with a 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 creating and nurturing 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
Eligibility Requirements
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
Additional Duties & Responsibilities
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 the 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
Compensation This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role‑specific variable or performance‑based bonus and/or other compensation elements. For an overview of our benefits please click
here .
Our Company Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths—and break new ground in the drive to make millions of lives better. Here, your development is our priority. We support you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after—as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you’ll be helping to transform lives for generations.
Want to learn more?
Visit our website
Seniority level: Mid‑Senior level | Employment type: Full‑time | Job function: Project Management and Information Technology | Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr