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Sr. Regulatory Affairs Specialist

Date: Apr 27, 2022

Location: South Haven, MI, US, 49090

Company: W. R. Grace & Co.

Requisition ID: 20470 

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 Summary

Grace is seeking a Senior Regulatory Affairs Specialist for our South Haven Site.  The South Haven Site produces a portfolio of products for the specialty pharmaceutical industries, specifically Active Pharmaceutical Intermediates.  Consisting of a cGMP kilo lab, pilot plant and custom manufacturing at the commercial volumes, the site is fully equipped to develop and manufacture custom drug intermediates and API’s.  South Haven is nestled on the Lake Michigan Coast with beautiful beaches and fun year-round. The Senior Regulatory Affairs Specialist will be 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. 

Job Description

  • 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

Required Skills

  • 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
  • Ability to understand FDA regulations and guidance documents

Required Qualifications

  • AA/AS degree with 2- 4 years of related experience OR
  • BA/BS degree with 1- 3 years of related experience
  • Experience in Quality Assurance, Quality Control or Regulatory Affairs


US Benefits

  • Medical, Dental, Vision Insurance
  • Life Insurance and Disability
  • Grace Wellness Program
  • Flexible Workplace
  • Retirement Plans 
  • 401(k) Company Match – Dollar to dollar up to the first 6%
  • Paid Vacation and Holidays
  • Parental Leave (salaried only)
  • Tuition Reimbursement
  • Company Donation Match Program
  • Site Specific contribution to local Wellness Center

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