Staff Regulatory Specialist (Pharmaceutical Products)

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:
+ 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.
Minimum requirements:
+ BS in Engineering, Science or related field. MS or RAC(s) preferred.
+ A minimum of 4-6 years? experience in Regulatory Affairs.
+ Must have pharmaceutical experience. 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.
+ Travel Required: Up to 25%
Work From Home: No
Travel Percentage: None
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer ? M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor?s legal duty to furnish information.
Stryker is one of the world?s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com

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