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Regulatory Affairs Professional 4

at Acara Solutions in Newark, Delaware, United States

Job Description

Acara Solutions is looking for a Regulatory Affairs Professional 4 for our Client located in Newark, DE.

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 client 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 needs documentation/information to local authorities or client 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.

"Creates"Is expected to adopt existing concepts, methodologies. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.

 

Pay and Benefits:

 

The salary for this position is $50.00 per hour (Max Pay rate).

 

 

Required Skills / Qualifications:

High school diploma or GED

Minimum 8 years' experience with Regulatory Affairs Professional.

Preferred Skills / Qualifications:

Masters domain and transfers and applies know-how to/in various contexts.

Solid professional judgment and problem solving competence.

Improves existing processes and approaches.

Additional Information:

 

Upon offer of employment, the individual will be subject to a background check and a drug screen.

 

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

 

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

 

Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.

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Job Posting: 854980

Posted On: Oct 08, 2021

Updated On: Nov 07, 2021