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AD/SR AD, US Product Group RA, US RRL - Cardio Renal Metabolic (

Description

For assigned development projects and US marketed products, the US Product Group RA, US RRL role will provide experienced US regulatory leadership 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
  • Utilize resources consistent with the overall goals and objectives of the (G)RA department.
  • Maintain current expertise on developments in the assigned therapeutic area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective.

 

This role provides strategic regulatory guidance to the Core Team and sub 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 drug laws. This role will also lead/participate regulatory sub teams of global projects, represent Global Regulatory Affairs, and provide global leadership and strategic planning to integrate sound regulatory practices into international drug development programs ensuring to follow regulatory standards, provide analysis, advise on, and implement strategies and policies, and stay updated on developments in the assigned therapeutic area from regulatory, scientific, pharmaceutical, pharmacovigilance, market access, and commercial perspectives.

 

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 global strategic expertise in therapeutic areas, effective cross-functional interaction, and influential advocacy to achieve project goals.

(2) RA Sub teams

  • Effectively lead RA sub-teams and ensure they have up-to-date project information to fulfill tasks and reflect global regulatory requirements.
  • Generate and align RSUs, ORION meeting content, management briefings, and presentations for the Regulatory Expert Group (REG).
  • Contribute to all project-related documentation, including management summaries and pre-reads for TALC, HPSC, and DC.

(3) Global Regulatory Strategy

  • Collaborate with the RA sub team to develop and implement global regulatory strategy, assess strategic options, and provide regulatory advice for development projects and product maintenance.
  • Optimize strategies considering global goals, regional requirements, and expedited regulatory pathways.
  • Lead the creation of a Global Regulatory Strategy document, coordinate input from RA sub team members, and ensure endorsement by relevant GRA functions.

(4) External/internal assessments, external partners

  • Support internal and external pre-evaluations, contribute to assessment reports, and fulfill RA tasks for projects with licensing partners as outlined in contracts.

(5) HA Meetings

  • Establish and adjust global strategy and goals for health authority meetings in alignment with Core Team and RA Sub team.
  • Support sTM RA(s) in defining regional-specific questions and content.
  • Collaborate with sTM RA to provide guidance, prepare briefing documentation, and plan regulatory agency meetings, attending as appropriate.

(6) General global regulatory considerations

  • Provide global strategic regulatory guidance and input to key development, registration, and commercialization documents, emphasizing company priorities.
  • Collaborate with Global Labelling to provide regulatory input on draft CCDS and support regional/local drug labelling discussions throughout the product lifecycle.
  • Lead global regulatory communications for safety or quality issues, coordinate responses to health authority questions, and support submission rollout for RoW countries, focusing on company priorities.

(7) Regulatory Intelligence

  • Evaluate worldwide regulations, trends, and developments for their impact on drug development activities, and develop contingency plans and risk/benefit analyses for assigned projects.
  • Represent GRA in cross-functional working groups, providing timely regulatory insights and guidance.

(8) Mentoring

  • Mentoring other GRA functions including RA sub team members and provide education to pharmacy students

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.  

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