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Regulatory Affairs Professional 4

at APN Software Services Inc. in Newark, Delaware, United States

Job Description

Description:

Analyzes the requirements and prepares product related regulatory submissions. * Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.* Identifies, analyzes and implements country specific requirements necessary for product related submissions.* Plans and prepares product related submissions with internal (e.g. Regional Units) or external organizations according to regulatory requirements.* Performs regulatory projects or acts as a member of the project steering group.* Submits required documentation/information to local authorities or internal.* Initiates and escalates necessary activities if deviations are identified.* Ensures creation of adequate documentation for audits/inspections.* Performs training within the organization in country specific regulatory requirements, if applicable.* Performs review of promotional material for regulatory compliance according to country specific requirements.* May represent the company in industry associations (Lobbying), if applicable. "Creates"Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements. 8-10 years Deep professional know-how and experience in one Sub Job Family. Masters domain and transfers and applies know-how to/in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches. 

 

 

 

As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.

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Job Posting: 853079

Posted On: Oct 04, 2021

Updated On: Nov 03, 2021