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22 days old

Senior Regulatory Affairs Specialist

Kelly Services
South Haven, MI 49090
**Senior Regulatory AffairsSpecialist**


**South Haven, MI**


**Full Time**


**M-F, 7:30AM-4:00PM**


Kelly Science & Clinical is looking for a **Senior Regulatory Affairs Specialist** to support an international high-performance specialty chemical and materials company in **South Haven, MI** .


**Responsibilities**


+ Prepares global regulatory documentation and registration in support of customers, and company's strategic business objectives; including but not limited to Drug Master Files, Annual Reports, and Supplements. Current Geographical areas of emphasis are North America, European Union, Pacific Rim, Central America, and South Africa.

+ Approves all Change Requests, Variations, etc. for compliance to filed DMF parameters.

+ Coordinates development, distribution, and revision of Customer Technical Packages.

+ Prepares responses to Customers.

+ Prepares and approves global label copy.

+ Prepares responses to regulatory agencies; including but not limited to Deficiency Letters, Establishment Registration, and Product Registrations.

+ Coordinates development of information necessary to complete filings with Analytical Services, Engineering, Manufacturing, Quality Control, Quality Assurance, and Research and Development.

+ Coordinates validation of all aspects of company operations, facilitates and processes for compliance to GMP, SOP and company requirements.

+ Participates in inspections of company by regulatory agencies.

+ Coordinates the company Record Retention Policy for QA and Regulatory Documents.

+ Prepares reports and recommendations to management based on review and analysis of regulatory enforcement trends.


**Qualifications**


+ 4 years experience and AA/AS degree, 3 years experience and BS/BA degree or 1 year experience and Masters Degree.

+ Experience in quality assurance, quality control or regulatory affairs is required


+ eCTD experience being a plus

+ Prior eCTD publishing & electronic processing experience.

+ Highly proficient computer skills including:

+ Adobe and MS Word

+ Electronic submission software (e.g. DocuBridge)

+ Windows and MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) or similar software


Send resumes to Jacqueline.Sayoc@KellyScientific.com


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-06-06 Expires: 2022-07-07

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Senior Regulatory Affairs Specialist

Kelly Services
South Haven, MI 49090

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