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Regulatory Affairs Specialist

Date: Nov 30, 2022

Location: South Haven, MI, US, 49090

Company: W. R. Grace & Co.

Requisition ID: 21092 

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

Grace is seeking a Regulatory Affairs Specialist to join our Fine Chemical Manufacturing Services team!  This role reports to the Quality Assurance and Regulatory Affairs Manager and is located at the South Haven, Michigan site.  The South Haven site produces a portfolio of products for the specialty pharmaceutical industries, specifically Active Pharmaceutical Ingredients.  Consisting of a cGMP kilo lab, pilot plant and custom manufacturing at commercial volumes.  South Haven is nestled on the coast of Lake Michigan with beautiful beaches and fun year-round.

Responsibilities

The 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.  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.  
  • 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 Qualifications

  • Minimum 2 years experience and Associate's degree
  • Minimum 1 year experience and Bachelor's degree
  • Experience in Quality Assurance
  • 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 good communication skills are required
  • Understanding of FDA regulations and guidance documents applicable to pharmaceutical manufacturing  #WRGRACE  #INDEED

Preferred Qualifications

  • eCTD experience
  • Past experience in a FDA regulated manufacturing environment
  • Master Control experience is a plus 

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