The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Pharmaceuticals, Quality/Risk Management, Regulatory Compliance
4 Year Degree
Accountability Objective: The Regulatory Affairs Specialist, Ad / Promo position reports directly to the SVP of Regulatory and is responsible for the daily support or management of regulatory requirements for Impel’s drug products, providing leadership on advertising and promotional materials, and developing and maintaining relationships with key client staff and regulatory bodies.
ESSENTIAL DUTIES AND RESPONSIBILITIES includes the following.
Provide regulatory guidance for the development, review, implementation, and maintenance of promotional materials and other related activities with minimal oversight
Chair promotional review committee meetings and effectively collaborate with cross-functional internal groups
Responsibility and oversight of promotional material submissions under Form FDA 2253
Manage the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary liaison with relevant personnel in FDA’s Office of Prescription Drug Promotion
Maintain current awareness of evolving health authority interpretations, including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders.
Manage, maintain, and continuously improve processes and systems (including a web-based platform) for review and approval of promotional materials
Act as a key regulatory affairs expert within the Impel regulatory team, providing expertise on regulatory strategy, process, filing, and best practices
Provide strategic and operational leadership for promotional, educational, and investigative communications
Review and evaluate materials submitted by Impel to ensure that the content, quality, and format comply with applicable laws, regulations, and company policy
Use extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to develop projects and marketed product regulatory issues to support Impel’s corporate objectives
Manage launch preparation of promotional material for TRUDHESA
Maintain knowledge of changing regulatory requirements and advise teams as appropriate
Represent the Impel Regulatory Affairs Team in meetings or workstreams; provide support for ancillary projects
Collaborative:Works together in an intersection of common goals by sharing knowledge, learning, and building consensus with others.
Flexibility: Develops new or diverse strategies to achieve organizational goals. Able to lead in a changing and challenging work environment. Manages competing demands and unexpected events.
Ownership: Demonstrates full ownership and takes accountability for the actions and execution of both self and the department.
Leadership: Ability to be dynamic and visionary, and able to define clear and specific objectives, tasks, and responsibilities.
Initiative: Measures self against a standard of excellence. Demonstrates persistence and overcomes obstacles, takes calculated risks to accomplish goals. Ability to work a demanding, primarily self-directed work schedule.
Professionalism: Works well in a fast-paced environment; treats others with respect and consideration; accepts responsibility for own actions. Understands business implications of decisions, aligns work with strategic goals. Meets deadlines and commitments.
Communication Skills: Clearly and persuasively communicates verbally and in writing. Listens and seeks clarification; manages difficult situations; maintains confidentiality.
Problem Solving: Conducts appropriate analysis and makes clear, consistent, and timely decisions.
Detail minded: Demonstrates accuracy and thoroughness; monitors own work to ensures quality and organization. Strong attention to detail while multitasking.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Sitting, standing, stooping, and lifting of packages/laboratory equipment up to 30 pounds may be required.
When based in the office or health clinic, expect a noise level typically moderate for offices.
PRIMARY LOCATION & TRAVEL
This position is not location specific with focus being on the right individual. We anticipate that on an ongoing basis this role will be a remote position although incumbent will need to participate in face-to-face meetings as needed. Travel up to 10% to meet the ongoing needs of the business.
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
At least 8 years of prior pharmaceutical regulatory affairs experience
Knowledge of FDA advertising and promotion regulations and guidance
Proactively monitors guidance, FDA current landscape and Federal Regulations
Work collaboratively with medical, legal, and marketing personnel on advertising and promotional materials
Internal Number: 1
About Impel NeuroPharma
At Impel NeuroPharma we are focused on developing and commercializing transformative therapies for people living with central nervous system (CNS) disorders through the pioneering of an optimized approach to drug delivery. Our investigational therapies are enabled by the Company’s proprietary upper nasal delivery technology, known as the Precision Olfactory Delivery, or POD®, device.