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Regulatory Affairs Specialist

Date: Sep 23, 2021

Location: South Haven, MI, US, 49090

Company: W. R. Grace & Co.

Requisition ID: 19360 

Built on talent, technology, and trust, Grace is a leading global supplier of catalysts and engineered materials. The company’s two industry-leading business segments—Catalysts Technologies and Materials Technologies—provide innovative products, technologies, and services that enhance the products and processes of our customers around the world. Grace employs approximately 4,300 people in over 30 countries.

Job Description

Responsible for day-to-day Regulatory Affairs activities including document change request reviews and approvals, regulatory agency submissions such an annual reports, Letters of Authorization, and Drug Master File amendments, in addition to responses to product specific customer inquiries.  Duties include:

  • 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.

Skills

Candidate must have:

  • Ability to work and collaborate with other departments including engineering, operations and research and development. 
  • Good computer skills, critical thinking skills, attention to details and ability to articulate their position or opinion to others in multi departmental meeting. 
  • Understanding FDA regulations and guidance documents.  

Required Experience

  • 2-4 years experience and AA/AS degree, 1-3 years experience and BS/BA degree.
  • Experience in Quality Assurance, Quality Control or Regulatory Affairs. 
  • eCTD experience is a plus.
  • Past experience in a FDA regulated manufacturing environment is a plus.  #WRGRACE

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.


Nearest Major Market: Kalamazoo