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.
Act as the regulatory core team member for, and provides regulatory guidance to combination product project teams in a fast paced, highly visible, complex, and at times ambiguous and changeable environment. Will provide guidance to other combination product regulatory professionals.
Ability to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner with excellent written and interpersonal communication skills.
Provides guidance on drug and device regulations, regulatory strategy, and pharmaceutical and design controls/design history file deliverables to other combination product regulatory professionals.
Is responsible for the creation of all submission documentation for a project with a large portfolio of products.This includes correspondence, meeting requests and dossier content, including labeling.
Set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation. Ability to work with all functional areas to obtain needed information on time.
Anticipates the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed.
Reviews scientific information to ensure the data is complete, sound, logical, and supports the program goals.
Partners with authors to ensure supporting information is clearly and logically written, in order to ensure it is submission ready.
Interact and effectively negotiate with regulatory authorities
Maintains awareness of applicable regulations and guidances and informs project teams of new information, along with its possible impact to the project, as appropriate.
Interprets regulations and ensures regulatory compliance. · Exercises good judgment within company policy and health authority regulations.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
PHYSICAL/MENTAL REQUIREMENTS: Must be able to work in an office environment and at a computer or on the phone throughout the day. The field of combination products is relatively new and in flux, both in the US and ex-US. The successful individual will embrace the ambiguity in how to meet the intent of both the device and pharmaceutical regulations simultaneously, the continual change in expectations, and the ability to possibly influence company precedent. This position requires an evaluation of the candidate’s writing skills.
Bachelor’s degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject; is required.
10-15 years of experience in regulatory affairs in Medical Devices or Combination Products.
Strong understanding of the intent of the regulations to wisely navigate the discrepancies that exist in the application of each set of regulations to combination products, in order to ensure the decisions work well throughout the lifecycle of the products and to set appropriate precedent for future products and projects.
A Master’s degree is preferred. A Ph.D. is highly preferred.
Previous experience with combination product regulatory strategy and/or execution is strongly preferred.
ADDITIONAL OFFER DETAILS
Eligible for Employee Referral Bonus: Yes
Additional Location Information: Lake Forest, IL or Kalamazoo, MI
Eligible for Relocation Package
Internal Number: 4771504
About Pfizer inc.
Pfizer Global Research and Development (PGRD), Pfizer’s discovery and development division, is one of the finest pharmaceutical research institutions in the world. Our focus is clear - to discover and deliver an ever-increasing variety of medicines to significantly enhance the health and quality of life for people and animals around the world. We accomplish this with multidisciplinary teams of scientists and technology professionals who perform exemplary science, innovation and extraordinary teamwork.
Pfizer’s success is evident in our industry-leading pipeline of drugs. Our search for new treatments spans hundreds of research projects across 31 major disease groups and therapeutic areas - more than any other company on the globe. Included are oncology, anti-infective and anti-virals, central nervous system, cardiovascular, diabetes, obesity, and ophthalmology. Pfizer is responsible for many recognized drug breakthroughs that rank first in sales in their class, including several with which you may be familiar -- Lipitor (for high cholesterol), Zithromax (an oral antibiotic), Norvasc (for hypertension), and Viagra (for erectile dysfunction).