Sr. Manager, Regulatory Affairs - Combination Products

Lake Forest, Illinois
November 16 2020
Position Type
Full Time
Organization Type
Job Type
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. ยท 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.

  • Eligible for Employee Referral Bonus: Yes
  • Additional Location Information: Lake Forest, IL or Kalamazoo, MI
  • Eligible for Relocation Package


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Regulatory Affairs