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Regulatory Affairs Submissions Specialist

Kelly Services


Location:
Round Lake, IL
Date:
04/23/2018
2018-04-232018-05-22
Job Code:
US33MXGR_BH1414880
Categories:
  • Government
  • Regulatory Affairs
Kelly Services
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Job Details

Job Title Regulatory Affairs Submissions Specialist

Jobid US33MXGR_BH1414880

Location: Round Lake, IL, 60073, USA

Description Kelly Services is seeking a **Regulatory Affairs Submission Specialist** for our customer **in Round Lake, IL** . This position is currently budgeted through the end of the year and is focused on writing of submissions to the FDA. Candidate must have experience on ownership and authoring US drug submissions (NOT MEDICAL DEVICE). Ideal candidates will also have experience in change control in US drug products including assessment, analysis, etc.; submission to FDA including prior approval; Changes Being Efficient (CBE); and creating annual reports.

Responsibilities:

• Compile and submit, in a timely manner, regulatory documents per regulatory requirements

• Prepare, review, and approve SOP’s as requested. Assist lower level team members on complex issues.

• Provide regulatory advice to project teams.

• Provide guidance and coaching for areas of responsibility to lower level team members.

• Respond to regulatory authorities’ questions with strict deadlines

• Maintain regulatory files in a format consistent with requirements

• Develop and initiate complex regulatory project plans

• Manage regulatory activities relating to specific portfolio of products/projects (product owner)

• Maintain and update existing regulatory authorizations

• Lead or represent Regulatory Affairs in project teams

• May review promotional material for compliance with regulations

Qualifications:

• Bachelor’s degree in pharmacy or related scientific discipline with a minimum of 2-3 years regulatory experience within a pharmaceutical company, CRO, or similar organization.

• Proficiency in Documentum, SharePoint, Word, Excel, PowerPoint, Outlook

• Exercise independent judgment

• Scientific knowledge

• Written and Verbal communication skills

• Knowledge of regulations

• Strong Negotiation skills

• Technical system skills (e.g. word processing, spreadsheets, databases, online research)

• Manage multiple projects and deadlines

• Ability to identify compliance risks and escalate when necessary

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Group rate insurance options available immediate upon hire*

• Service bonus plan and holiday pay*

• Online application system

• Never an applicant fee

*perks to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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