Description

For assigned development projects and US marketed products, the US Product Group RA, US RRL role will provide experienced US regulatory strategic input to the global and US cross-functional teams. They will also provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance as well as act as primary company liaison with the US Food and Drug Administration. This role will primarily be focused in the therapeutic area of Cardio Renal Metabolic. (CRM).

Provide analysis, advice and guidance on US regulatory strategies.
Provide expertise on regulatory standards and departmental policies
Maintain current expertise on developments in the assigned therapeutic area from the regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective.

This role provides strategic regulatory guidance to regulatory and cross-functional teams, challenges development programs scientifically, and manages all regulatory aspects through the development and maintenance of new medicinal products and indications. The role is accountable for the global development of investigational products towards submission, approval, and regulatory maintenance, ensuring compliance with US drug laws.

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 a number of 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.

Duties & Responsibilities

(1) Regulatory Professionalism:

Regulatory expert with US focused strategic expertise in CRM therapeutic area, effective cross-functional interaction, and influential advocacy to achieve project goals.

(2) Global Project Team Support:

Contribute to all project-related documentation, including management summaries and pre-reads for various management committees.
Lead the development and implementation of US regulatory strategy within a global context, providing US regulatory advice and assessing strategic options.
Define US strategic considerations for expedited regulatory pathways and contribute to the Global Regulatory Strategy Document and draft CCDS.
Provide US guidance to the global team on FDA submissions, meetings, and pediatric development requirements, including documentation preparation.

(3) US Focused Project Team Support:

Provide strategic US regulatory input and advice to cross-functional teams during development, registration, and marketing approval considering regulatory precedence and FDA guidance.
Contribute to US RA efforts on draft labeling for FDA submission, ensuring appropriate supportive information is included.

(4) Health Authority Meetings

Manage all FDA interactions for assigned projects/products, including meetings, review of registration packages, labeling negotiations, and submissions.
Establish and implement US regulatory strategy for FDA meetings, ensuring alignment with project teams and RA subteam, and lead FDA meetings.
Provide regulatory leadership to prepare responses to FDA requests and disseminate FDA interactions within Boehringer Ingelheim.

(5) General global regulatory considerations:

Provide US regulatory guidance for key development, registration, and commercialization documents, emphasizing US contributions within strategic priorities.
Lead the preparation and distribution of critical safety or quality communications in the US, with guidance from management and relevant teams.

(6) Regulatory Intelligence:

Evaluate US regulations, trends, and developments for their impact on drug development activities, and develop contingency plans and risk/benefit analyses for assigned projects.
Share new/novel "on the job" US regulatory intelligence/experience with peers, as appropriate

Requirements

Education Requirements:

Minimum of Bachelor's degree required; Advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's) preferred
Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification preferred

Associate Director Experience Requirements:

Two (2) years of professional experience in a scientific, clinical, and/or medical space.

Sr. Associate Director Requirements:

Five (5) years of professional experience in a scientific, clinical, and/or medical space.

Additional Requirements:

Requires a robust and broad range of US regulatory experience and knowledge, from both strategic and operational perspectives.
Medical, pharmaceutical and scientific knowledge and understanding in the assigned therapeutic area. Extensive experience demonstrated in managing all aspects of FDA liaison activities.
Experience within the therapeutic area of Cardio Renal Metabolic (CRM).
Critical thinker with ability to self-direct workload, including reprioritizing and delivery under tight timelines.
Ability to analyze and interpret scientific data and regulatory guidelines.
Strong interpersonal skills supporting the ability to influence without authority, develop effective professional relationships, work in a matrixed team environment, and demonstrate sound conflict management and negotiation skills along with the flexibility and willingness to adapt to a changing environment.
Leadership, sound decision-making, negotiation and problem-solving skills in an independent manner with an overall strategic view and a strong business acumen.
Excellent oral and written communications skills with the ability to provide key messages in a concise manner.
Excellent meeting preparation and presentation skills.
Demonstrated understanding of the regulatory process and technical competence in core areas of drug development.
(In-depth) knowledge in RA gained through direct regulatory liaison with US FDA Understanding of and fluency with:
- Food, Drug and Cosmetic Act
- 21 CFR regulations relevant to drug/biologic development and registration
- Other relevant US laws, regulations and guidance documents

Compensation Data

This position offers a base salary typically between $140,000 and $222,000 for the Associate Director role and between $170,000 and $269,000 for the SR Associate Director role. 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.