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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 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 delivers project management support to the Global Regulatory Lead (GRL) and Regulatory Excellence Team (RET) with a focus on regulatory strategy execution, translation of regulatory strategy into actionable plans and project progress across the lifecycle of assigned projects, even complex ones (e.g., multiple indications, multiple assets, pivotal phase studies). This role maintains reporting and tracking of key project metrics (milestones, timelines, resourcing, documentation, execution, key performance indicators (KPIs)) for the team and governance decisions. The incumbent ensures project delivery in alignment with agreed upon regulatory strategy, timeline and deliverables.

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 asset 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 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.

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, 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.

**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.

Desired Skills, Experience and Abilities

**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 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. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.