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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 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 coordinated by the Regulatory Project Manager.
Support submission rollout for Rest of World (RoW) countries from the global strategic perspective.

Registration & lifecycle management:

Contribute to and oversee execution of strategies for the lifecycle management of assigned marketed products, including assessing the need for post-approval changes, such as variations, supplements, and line extensions, and developing regulatory plans to implement these changes globally.
Collaborate with Evidence & Asset teams to ensure alignment with business goals and regulatory requirements.

Regulatory intelligence:

Stay up to date with and evaluate relevant worldwide regulations and guidelines, evolving regulatory trends and developments, impact on drug development activities and determine impact on existing strategies, products and submissions.
Proactively communicate the impact of regulatory changes to internal stakeholders and provide recommendations on adapting regulatory strategies.
Develop and advises on contingency plans for assigned projects.
Provide timely risk/benefit analyses of issues affecting products/projects.
Continuously scan the relevant environment for innovative regulatory pathways and perform insightful competitive landscape analysis.

Requirements

Bachelor's degree in pharmacy, life sciences or chemistry with seven (7) years' experience in regulated pharmaceutical industry (biologics or small molecule) required.
Preferred: Master's Degree or Doctoral Degree (e.g., PhD) in pharmacy, life sciences or chemistry with five (5) years' experience in regulated pharmaceutical industry (biologics or small molecule)
Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification

Technical expertise:

In-depth knowledge of latest regulatory science and global regulatory requirements, guidelines, developments, and standards, allowing for informed comments and input to a broad spectrum of key regulatory documents, challenges, and infliction points.
Demonstrated thorough understanding of the regulatory process and technical competence in core areas of drug development and can analyze and interpret complex scientific data and regulatory guidelines.
Interprets and translates regulatory guidance to project specific proposals and proactively provides guidance to the creation of compliant, strategically thought-through and innovative regulatory solutions to emergent issues.
Commercially aware and has a thorough understanding of the business environment, needs and priorities of the company, the assigned TA and the contribution of specific assigned development and PMO projects.
Able to work autonomously in a highly efficient manner.

Soft skills:

Critical thinker with ability to self-direct workload, including prioritizing and delivering under tight timelines.
Strong strategic mindset & thinking, with the ability to step out of everyday details and provide a top-down view, i.e.:
Adaptability, learning agility and flexibility in navigating changing regulatory environment and adapt strategies accordingly, including:
Can-do attitude and a proactive approach to work, demonstrating a willingness to take ownership and find solutions for addressing regulatory challenges and opportunities, including:
Effective leadership and team management skills
Strong interpersonal skills, relationship building, sound conflict management skills.
Excellent verbal and written communications skills
Ability to summarize complex scientific and regulatory questions into easy-to-read slides and text.
Ability to prepare scenarios and decision trees, helping decision-making within the evidence and asset teams.
Strong organizational and time management skills
Fluency with necessary computer software (MSWord, Excel, Project, etc.)

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

Regulatory policy & external stakeholder interactions:

Contribute to global strategy and for meetings with health authorities for drug development goals in alignment with Evidence and Asset Team and RET.
Collaborate to define the policy and environment shaping goals, regional-specific questions and content.
Provide guidance and input to regulatory agency meetings including briefing documentation.
Provide global regulatory input to critical safety or quality communications.
Maintain global oversight of local RA activities in responding to local health authority questions.
Attend and seek out Health Authority meetings for assigned projects.
Stay informed about evolving regulatory expectations, provide input on policy developments, and contribute to shaping regulatory frameworks for better patient outcomes.

External / internal assessments, external partners:

Participate and support internal and external pre-evaluations and contribute to assessment reports.
For projects with a licensing partner, fulfill RA tasks as outlined in the licensing contract.
Proactively drive continuous improvement and increasing efficiencies.

RA sub team leadership:

Ensure active involvement in shaping robust strategies aligned with business goals.
Encourage innovative thinking and a proactive approach to anticipate regulatory challenges & opportunities.
Oversee up to date project information shared by Regulatory Project Manager to ensure sub team members can fulfill their assigned tasks and seek input from RA sub team / RET to accurately reflect global regulatory requirements and challenges in the Evidence Team.
Responsible for the GRA contribution to key project related documentation.
Ensure the sub team / RET is appropriately staffed and possesses the necessary skills.

Mentoring:

Act as a mentor to foster a collaborative environment where team members can seek feedback and discuss challenges.
Encourage the sharing of experiences and best practices.
Contribute to internal training programs, workshops, and knowledge-sharing sessions.
Attend relevant conferences, workshops, webinars and professional development courses, e.g., Advanced Analytics or AI and becoming a translator on how to use these technologies.

Represent GRA on the Evidence Team:

Actively collaborate with Evidence and Asset teams to align regulatory strategies with product development plans.
Proactively provides regulatory input and options during all stages of product development.
Jointly problem-solve to address issues and find innovative solutions.
Keep team informed about regulatory developments, changes, and approvals.
Provide regular updates on regulatory milestones and their impact on the overall project timeline.
Prepare teams for regulatory meetings, advisory committees, and inspections with a unified approach.

This position offers a base salary typically between $228,000 and $350,000. 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.