Regulatory Project Manager

The Position

Boehringer Ingelheim is seeking an exceptional individual to provide project management support to our Global Regulatory Strategy Lead (GRSL) and Regulatory Excellence Team (RET) as Regulatory Project Manager.
In this pivotal role, you will be at the forefront of regulatory strategy execution, translating complex strategies into actionable plans and driving project progress across the lifecycle of assigned projects. Your work will be instrumental in managing brands, pivotal phase studies, and multiple indications.
As a key member of our team, you will maintain reporting and tracking of crucial project metrics, ensuring project delivery aligns with our regulatory strategy, timeline, and deliverables. Your expertise will be vital in creating and updating the critical path for submission, coordinating interactions with key stakeholders, and inspiring the team to embrace agile ways of working.
This is a fantastic opportunity to work with cross-functional stakeholders, coordinate regulatory input into the overall brand strategy, and support the submission team in Regulatory.
If you are passionate about making a difference and ready to contribute to a team that values speed and effective execution, we would love to hear from you. 

Tasks & responsibilities

• As a key player in our team, you'll be accountable for translating complex regulatory strategies into actionable plans. Your visionary thinking will guide our projects and set the course for our success.
• In collaboration with the GRSL (Global Regulatory Strategy Lead), you'll create and manage regulatory project plans, timelines, and interdependencies. Your skills will ensure the delivery of end-to-end submissions, coordinating with various teams to gather the necessary data and documents for submission.
• Your meticulous attention to detail will ensure proper project documentation, tracking regulatory actions from pre-IND (Investigational New Drug) to MAA (Marketing Authorization Application) submission. As a Regulatory Project Manager, you will own and maintain the Regulatory Project Plan, serving as the gatekeeper of our regulatory strategy, key decisions, and roadmap — ensuring all information is up-to-date, consistent, and aligned across stakeholders.
• You will manage the execution of critical regulatory project deliverables by coordinating activities across Global Regulatory Affairs and cross-functional stakeholders. This includes managing the internal Regulatory Excellence Team (RET) to drive regulatory readiness and alignment within GRA, as well as managing the cross-functional Submission Deliverable Team (SDT) to coordinate planning and execution of complex regulatory submissions. Through strong facilitation, stakeholder management, and governance, you will ensure accountability, effective decision-making, and timely delivery of key regulatory milestones.
• You'll set up effective team communication channels, ensuring alignment within the RET (Regulatory Excellence Team). Your excellent communication skills will ensure key decisions are communicated to stakeholders, and actions are logged, tracked, and acted upon.
• Finally, you will embrace and drive agile ways of working within the team, facilitating sprint planning, daily stand-ups, and retrospectives. Your relentless drive for prioritization, efficiency, and speed will inspire the team and ensure the successful execution of our regulatory strategy.

Requirements

• Master’s Degree in life sciences, pharmacy, chemistry, or business administration or a Bachelor’s Degree with more relevant experience; higher academic degree and/or an advanced certification in project management is a bonus.
• Several years of experience in the pharmaceutical or biotechnology industry with a proven track record in independently managing project delivery in the area of drug development processes and key stages of product development, demonstrating a deep understanding of process management, and consistently delivering within agreed parameters.
• Familiarity with the overall drug development process and key stages of product development is required, knowledge of regulatory aspects and submissions is a definite advantage.
• Proficient in project management processes and tools, including database handling and tracking tools as well as familiarity with project management software and pharmaceutical industry-specific software are a must.
• Experience in agile working methods and know-how on bridging agile and traditional ways of working is required, expert knowledge of agile principles and practices is a plus.
• Critical thinking skills, strong communication abilities, and a proactive approach to problem-solving as well as a strong mentorship mindset, the ability to manage timelines effectively, and a knack for finding opportunities for standardization across projects.
• Business proficiency in English, German language skills are an advantage

As part of our commitment to transparency and fairness, salary information will be shared during the recruitment process. We also offer a comprehensive benefits and wellbeing package.
Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process. 

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Recruitment process:
Step 1: Online application - The job posting is presumably online until September 1st, 2026. We reserve the right to take the posting offline beforehand.
Step 2: Virtual meeting until mid-September.
Step 3: On-site interviews beginning mid-September.