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Eurofins

Regulatory Affairs Specialist

Post Date:Jan 12, 2019Type:Full-Time
Start Date:1/12/2019Salary:
Location:US-MI-Kalamazoo Job Reference:14861
Skills:
 

Job Description:
Regulatory Affairs Specialist

Employee Responsibilities:
  • Support regulatory activities for post-approval manufacturing changes or site transfers
  • Prepare responses to global Health Authority queries including FDA/CVM for post-approval MCSR incomplete letters or post-approval manufacturing changes.
  • Gain knowledge and awareness of emerging global CMC regulations and assist in the development of client regulatory positions and strategies
  • Develop strong working relationships and act as primary interface with both client manufacturing sites and contract manufacturing interfaces for assigned portfolio.
  • Develop knowledge of CMC regulatory science
  • Work with departments within the client's organization to ensure appropriate alignment and sharing of best practices
The Ideal Candidate would possess:
  • Strong computer, scientific, and organizational skills
  • Excellent communication (oral and written) and attention to detail
  • Good negotiating skills
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Understanding of pharmaceutical manufacturing processes, including GMPs
Minimum Qualifications:
  • Bachelor's degree in biology, chemistry, or other related degree concentration, or equivalent directly-related experience
  • At least two years of technical/scientific/pharmaceutical and/or regulatory experience with global pharmaceutical registrations
  • Authorization to work in the United States indefinitely without restriction or sponsorship
What we offer:
  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Kalamazoo, Michigan are encouraged to apply.

Eurofins Lancaster Laboratories Professional Scientific Services ® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.





Contact Information
Eurofins
Name: Eurofins


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