Director, US Product Group Regulatory Affairs, Mental Health/Eye Health

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.

*This role requires you to work on a hybrid schedule meaning 2-3 days per week at our Ridgefield, CT location*

For assigned development projects and US marketed products, the Director, US Product Group Regulatory Affairs will provide expert US regulatory leadership to the global and US cross-functional teams throughout the product lifecycle. This role will provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance. As a member of the Regulatory Excellence Team, the position holder will provide US regulatory input into the Global Regulatory strategy for assigned projects and represent US RA on US cross-functional teams.

The Director, US Product Group Regulatory Affairs will act as primary company liaison with the US Food and Drug Administration. This role will develop comprehensive, well-thought through US regulatory strategies to navigate the intricate US regulatory landscape, ensuring compliance with relevant guidelines and regulations. The incumbent 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 US regulatory pathways. This role will collaborate closely with US stakeholders to align US regulatory strategies with the overall business objectives.  

The Director, US Product Group Regulatory Affairs will maintain current expertise on developments in the assigned therapeutic area from a global regulatory, legislative, scientific, pharmaceutical, pharmacovigilance, market access and commercial perspective. This role will engage in US regulatory policy development and foster external stakeholder interactions. The incumbent will provide expertise on regulatory standards and departmental policies.

The Director, US Product Group Regulatory Affairs will proactively participate in US/global cross-functional meetings and discussions, ensuring that US regulatory considerations are incorporated timely and comprehensively at key inflection points and in the decision-making process. This role is an advocate for US regulatory excellence and drive alignment between regulatory strategies and overall project and business goals.

Duties & Responsibilities

Regulatory Professionalism:

• Seamlessly interacts and collaborates effectively at all levels organization (local and global) within RA and across functions.
• Advocates to effectively, efficiently and proactively drives project goals, presenting well-grounded, strategically thought-through options and arguments to independently achieve success regulatory outcomes.
• Maintains the highest stands of professionalism, ethics, and regulatory compliance.

Regulatory Excellence Team (RET)and Intra-RA Project Responsibilities:

• Recognized expert in contributing a broad range of US operational and strategic perspectives to Regulatory Excellence Team (RET).  
• Actively collaborates with RET to align regulatory strategies with product development plans.
• Proactively provides regulatory input and options during all stages of product development to ensure potential challenges and requirements are addressed from the start.
• Jointly problem-solves to address issues and find innovative solutions that align with business objectives while meeting regulatory standards. Shares successful use cases, where applicable.
• Provides regular updates on US regulatory milestones and their impact on the overall project timelines.
• Presents or supports review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate. 
• Independently ensures US RA contributions to all local and global project related documentation (e.g., Global RA Strategy, Risk Assessments, Labeling) are clear, complete and accurate, taking on leadership of the content/information, as appropriate.

Other Regulatory Contributions:

• Provides US regulatory leadership in the preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with input/guidance from management, GRSL, US Legal, and PSPV, as appropriate.
• With supervision, represents US RA during internal and external audits and Health Authority inspections.

Pre-evaluations and External Partnerships:

• Provides expert US regulatory input and guidance to internal and external pre-evaluation teams (e.g., Due Diligence) and contribute to assessment reports.
• For projects with a CRO or licensing partner, provides and implements US RA strategic and operational perspectives/tasks, as appropriate.

US-Focused Project Support:

• Leads the development of IND/NDA/BLA submission ready documents, including but not limited to briefing packages, Special Designation Requests, etc. 
• Prepares and reviews IND/NDA/BLA annual reports (e.g., DSURs/PSURs) and PBRERS/PADERS with a focus on US specific sections.
• Ensures compliance with submission in accordance with regulatory timelines. 
• Provides US strategic regulatory guidance and input to key internal development, registration and commercialization documents for assigned projects (e.g., development plans, protocols, clinical trial reports, pediatric development plans, core dossier elements, integrated brand plans, market access documents), with particular emphasis on the US contribution.
• Provides seasoned US regulatory strategic guidance and inputs leadership and advice to US cross-functional teams during development, registration, and marketing approval for complex programs.
• As a member of the Product Labeling Review Team (PLRT), provides seasoned US RA strategic input and leadership in line with approved processes to prepare initial proposed draft labeling for submission to FDA ensuring appropriate supportive information is provided.

Requirements

• Bachelor’s Degree in life sciences, pharmacy, or chemistry with extensive drug development experience/knowledge with a minimum of ten (10) years’ experience in Regulatory Affairs, FDA, or equivalent experience in the regulated pharmaceutical industry (biologics or small molecules) required.

OR

• Doctoral Degree (e.g. PharmD, PhD) and/or Master’s Degree in life sciences, pharmacy, or chemistry, with drug development experience/knowledge with a minimum of eight (8) years of experience in Regulatory Affairs, FDA, or equivalent experience in the regulated pharmaceutical industry (biologics or small molecules) preferred.
• Expertise in multiple therapeutic areas and broad range of regulatory and drug development topics.
• Applies advanced critical thinking with the ability to self-direct workload, including prioritization and timely execution of deliverables in a fast-paced regulatory setting. 
• Lead team performance under pressure, cultivates a culture of adaptability, and leads strategic responses to regulatory and organizational shifts.
• Demonstrated advanced interpersonal skills, sound-decision making, and leadership capabilities, fostering strategic partnerships and influencing cross-functional stakeholders across the organization.
• Navigates complex, matrixed environments with agility, reprioritizing effectively in response to shifting regulatory and business landscapes.
• Applies seasoned negotiation and conflict resolution skills to align teams and drive regulatory outcomes that support organizational objectives.
• Drives strategic negotiations and proactively addresses high-impact regulatory issues, balancing risk and opportunity while aligning with organizational priorities and business strategy.
• Excellent oral and written communication skills with the ability to provide key messages in a concise manner.
• Exceptional organizational and time management skills to oversee multiple strategic projects and initiatives simultaneously. Ensures timely execution of high-impact deliverables, drives operational excellence, and maintains composure and focus under pressure in complex, fast-paced regulatory environments.
• Strong strategic mindset & thinking, with the ability to step out of everyday details and provide a top-down view.
• Can-do attitude and a proactive approach to work, demonstrating a willingness to take ownership and find solutions for addressing opportunities.
• Demonstrated understanding of the regulatory process and technical competence in core areas of drug development.
• Leads the interpretation of scientific and regulatory data across projects, translating insights into actionable strategies that align with local/global regulatory expectations and business objectives.
• Advanced proficiency in regulatory information management systems (RIMS), electronic document management systems (EDMS) and submission software (e.g., eCTD tools), along with advanced skills in Microsoft Office Suite.
• Excellent meeting preparation and presentation skills.

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:

• Leads all FDA interactions on assigned complex projects/products, including formal meetings, FDA review of registration packages, and labeling negotiations.  
• Establishes and implements US regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RET.
• In collaboration with the RET and project teams, leads development of FDA submission documents (e.g., briefing documents), through defining US-specific questions and content.
• Provides seasoned regulatory leadership to ensure alignment with global and US team/management, as appropriate, in preparing FDA request responses.
• Disseminates FDA interactions within organization, as appropriate.
• Manages all formal submissions and informal communications to FDA for assigned projects/products, including INDs and marketing authorization applications for complex programs.
• Recognized expertise in regulatory intelligence for assigned therapeutic area.
• Proactively and critically evaluates relevant US regulations and guidelines, as well as evolving regulatory trends and developments to determine impact on existing strategies, products and submissions.
• Proactively communicates the impact of regulatory changes to internal stakeholders and provide recommendations on adapting regulatory strategies, as appropriate.
• Provides input on the development of contingency plans for assigned projects as necessary.
• Provides timely risk/benefit analyses (including pros & cons, potential options and assessment of business implications) of issues affecting products/projects by continued monitoring of available US regulatory and competitor information.
• Shares new/novel "on the job" US regulatory intelligence/experience with peers, as appropriate.
• Drafts and presents overviews of US regulatory topics, as appropriate.
• Independently engages and represents Boehringer Ingelheim with external industry/consortia per department and TA needs.
• Independently interfaces and represents US RA with cross functional working groups and/or Gov’t Affairs on specific topics, as needed.
• Engages in proactive and collaborative relationships to stay informed about evolving regulatory expectations, provides input on policy developments, and contributor to shaping US regulatory framework for better patient outcomes.
• Collaborating with GRSL and RET, provides seasoned leadership in the development and implementation of US regulatory strategy within a global development context including complex projects. 
• Independently assesses and presents US regulatory risks, strategic options and opportunities to support assigned global development projects and Asset Maximization.
• Anticipates potential challenges and propose innovative solutions to accelerate the development and approval process leveraging the full breath of expedited regulatory pathways and most up-to-date regulatory science.  
• Defines US RA strategic considerations in the generation of global project related documents (e.g., Global RA Strategy, Risk Assessments).
• Collaborates with US/Global Labeling on early target label profile shaping, to ensure labeling is aligned with regulatory requirements and business objectives (e.g., competitive differentiation).

This position offers a base salary typically between $220,000 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.