Ridgefield, CT Director, Global Regulatory Strategy Lead (Eye Health) Remote Unit

Job 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. This position can be filled in different countries. If you want to apply for the position in the Germany, please use this link: Global Regulatory Strategy Lead Job Details | BoehringerPRD If you want to apply for the position in United States, click "Apply now" 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