Regulatory Affairs Specialist
ManpowerGroup
Our client, a leader in the pharmaceutical industry, is seeking an Associate Compliance Specialist to join their team. As an Associate Compliance Specialist, you will be part of the Regulatory Affairs department supporting compliance initiatives. The ideal candidate will have strong problem-solving skills, excellent attention to detail, and solid organizational skills which will align successfully in the organization.
**Job Title:** Associate Compliance Specialist
**Location:** Lake Zurich, Illinois
(Requires availability to work onsite 3 days a week - Wednesdays a MUST **)**
**What's the Job?**
+ Manage product data on both internal Regulatory Affairs and external FDA data tracking/collection databases to ensure the company’s products, processes, and physical sites continue to operate in a legal and ethical manner.
+ Maintain current knowledge of federal and international regulations/standards/guidance documents, and internal policies and procedures to ensure compliance within Regulatory Affairs.
+ Prepare, verify, and/or maintain technical files pertaining to submissions or other FDA-required activities throughout the product lifecycle.
+ Understand and support the regulatory implications of the product profile.
+ Other duties as assigned by management.
**What's Needed?**
+ Minimum of Bachelor's Degree, preferably in a scientific discipline.
+ 1-3 years experience in pharmaceutical Regulatory Affairs (experience in Quality Assurance will be considered in lieu of Regulatory Affairs experience).
+ Strong problem-solving and critical thinking skills.
+ Excellent written, verbal, and non-verbal communication skills.
+ Strong technical (system) and computer skills with proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint, etc.).
**What's in it for me?**
+ Opportunity to work in a dynamic and supportive environment.
+ Potential for assignment extension or conversion to full-time employment based on performance and business needs.
+ Hybrid work setup: 2 days remote and 3 days onsite.
+ Work schedule: 8am-5pm, Monday-Friday, with potential for overtime depending on workload.
+ Engagement in meaningful work that contributes to the compliance and integrity of the company’s products.
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
**About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells**
_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
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