Staff Regulatory Specialist (Pharmaceutical Products) - 28056BR - EN in Cary, IL at Stryker Corporation

Date Posted: 5/13/2018

Job Snapshot

Job Description

Who we want

Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
Achiever. Strong work ethic with a “leads by example” mindset.
Deliberative. Good judgment with ability to identify risks and make sound decisions.
Learner. Demonstrated commitment to learning and the ability to transfer knowledge, ideas and concepts.
Collaborate. Builds and maintains relationships cross functionally as well as externally to create opportunities.
Communicator. Articulates well and expresses ideas effectively.

What you will do

As a Staff Regulatory Specialist, you will be exposed to a diverse product portfolio that includes pharmaceutical, cosmetic and medical device products. This role is part of a growing and evolving Regulatory Affairs team that is focused on aligning and integrating to the Stryker global business. The ideal candidate will have strong project management skills including the ability to communicate effectively to a diverse set of stakeholders.

In this role, you will be responsible, but not limited to the following:
  • Prepare and author FDA required Annual Reports for New Drug Applications.
  • Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation.
  • Assess and author amendments and supplements to product marketing applications.
  • Provide regulatory guidance to other departments for planned changes.
  • Provide a critical detailed review of technical documentation prior to FDA submission.
  • Compile information and data pertaining to regulatory and project requirements including assessing needs; identifying the project’s critical factors; presenting decision-makers with options; and applying strategies.
  • Communicate with regulatory agencies regarding pre-submission strategies/regulatory pathway development, submissions and follow-up on submissions in review.
  • Serve as partner to marketing, engineering, clinical and quality on project and product development teams.
  • Improve awareness, visibility and communication on regulatory requirements to support company goals and priorities.

Job Requirements

What you need
  • BS in Engineering, Science or related. MS or RAC(s) preferred.
  • A minimum of 4-6 years’ experience in Regulatory Affairs.
  • Must have pharmaceutical experience. Additional experience with medical device products would be a plus.
  • Experience as primary liaison to regulatory authorities as well as experience authoring, reviewing and managing components of regulatory submissions is required.
  • Travel Required: Up to 15%

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