Menu

Regulatory Affairs Professional

at Acara Solutions in Newark, Delaware, United States

Job Description

Acara solutions is looking for Regulatory Affairs Professional 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 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
Performs review of promotional material for regulatory compliance according to country specific requirements.
May represent the company in industry associations (Lobbying), if applicable.
"Transfers"Is expected to integrate processes and results from other workflows and disciplines to develop and accountably propose appropriate and effective solutions.
Pay and Benefits:

The Salary for this position is $ 42.06 per hour (Max Pay rate).


Required Skills / Qualifications:
High School Diploma or GED
Minimum 5 years' experience as Regulatory Affairs Professional
Preferred Skills / Qualifications:
Deep professional know-how and experience in one Sub Job Family.
Masters domain and transfers and applies know-how to/in various contexts.
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.

Copy Link

Job Posting: 983431

Posted On: Jun 06, 2022

Updated On: Jul 06, 2022