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Director, Global Regulatory Strategy Lead

4 months ago

Ridgefield, United States BI Pharmaceuticals, Inc. Full time

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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Director, Global Regulatory Strategy Lead will provide strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects. This role will develop and own the Global Regulatory Strategy for assigned assets, lead the Regulatory Excellence Team (RET) and represent Global Regulatory Affairs (GRA) on the Evidence Team.

The Director, Global Regulatory Strategy Lead will craft comprehensive, well-thought through regulatory strategies to navigate the intricate global regulatory landscape, ensuring compliance with relevant guidelines and regulations. This role will assess regulatory risks, options and opportunities, anticipate potential challenges and propose innovative solutions to accelerate the development and approval process, leveraging the full breadth of regulatory pathways. The incumbent will collaborate closely with stakeholders to align regulatory strategies with the overall business objectives. The incumbent will keep up to date on developments in the assigned therapeutic area from the global regulatory, scientific, pharmaceutical, pharmacovigilance, market access and commercial perspective as well as engage in regulatory policy development and foster external stakeholder interactions.

The Director, Global Regulatory Strategy Lead will lead and guide the RET. Provide mentorship, direction and support team members, fostering a culture of excellence and continuous learning. This role will facilitate effective communication and collaboration among team members, encourage cross-functional coordination and coordinate with the (senior) regulatory project manager to achieve regulatory milestones & deliverables. The incumbent will promote a proactive and solution-oriented approach.

The Director, Global Regulatory Strategy Lead will serve as the main GRA representative on the Evidence Team. The incumbent will proactively participate in cross-functional meetings and discussions, ensuring that regulatory considerations are incorporated timely and comprehensively at key infliction points and in the decision-making process. This role will advocate for regulatory excellence and drive alignment between regulatory strategies and overall project and business goals.

**Duties & Responsibilities**:
Regulatory professionalism:

- Effectively lead with in-depth expertise in at least one TA and a broad range of global regulatory and drug development topics.
- Seamlessly interact and collaborate cross functionally at all levels of the organization.
- Drive project goals effectively, efficiently, and proactively, presenting well-grounded, strategically thought-through options and arguments to achieve successful regulatory outcomes. Maintain the highest standards of professionalism, ethics, and regulatory compliance.Global regulatory strategy:

- Lead the development and implementation of well-informed, cutting-edge strategic regulatory guidance and leadership of assigned projects, in collaboration with the RA sub team / RET and Evidence Team.
- Assess and present regulatory risks, options and opportunities, anticipate challenges and propose innovative solutions to accelerate the development and approval process, leveraging the full breadth of regulatory pathways and most up-to-date regulatory science.
- Support pivotal moments in the lifecycle of assigned projects in close alignment to Evidence & Asset Teams.
- Account for and optimize global regulatory strategy contribution around global business goals, focus country prioritization and regional requirements.
- Anticipate regulatory hurdles and proactively plan strategies to overcome them. Collaborate closely with stakeholders across the organization to align regulatory strategies with overall business objectives.Further asset development activities:

- Collaborate with stakeholders on early target label profile shaping, to ensure labelling is aligned with reg, requirements & business objectives.
- In cooperation with Global Labelling, provide global regulatory input into content of the draft Company Core Datasheet; support RET members in regional/local discussions related to the content of drug labelling during development, submission preparation, submission review and product lifecycle.
- Oversee the planning and execution of regulatory submissions coordina