Mar 14, 2019

Regulatory Compliance Specialist

  • Catalent Pharma Solutions
  • Kansas City, MO, USA
Full time Regulatory

Job Description

Job Description

Position Overview: 

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries.

The Regulatory Compliance Specialist will support the state of regulatory compliance at the Kansas City, MO site through the following programs: Quality Technical Agreements, Commercial Data Reports, Licensing and Regulatory Inspections or other related regulatory compliance issues and actions.

The Role/Daily Duties:

  • Provided support of the Quality Technical Agreements (QTA) program according to standard operating procedures and regulatory requirements including new QTAs and the required review of existing QTAs.  Involves direct interaction with Customers, Project Management, QPs, Quality at other Catalent sites and Catalent Corporate Compliance for the generation and approval of QTA.
  • Support the Commercial Data Report program including schedule creation/revision and opening meetings to assure completion of Commercial Data Reports by the communicated due date in support of the Customer’s Annual Product Review and bi-annual updating of the Drug Product Listing.
  • Support regulatory inspections and other quality or regulatory 365 activities.  Pre and Post Inspection activities may include:  opening presentation preparation, back room participant, retrieval and/or review of documentation, contact for SMEs, client notifications, investigations, updating of annual statements and other tasks as required.
  • Client regulatory submission support, as required.
  • Aide in the annual updating of the Site Master File.
  • Alternate for state licensing.
  • Update Quality standard operating procedures and forms as required.

The Candidate

Education or Equivalent:

  • Associates degree and 5+ years of related Scientific or Quality Assurance Experience.
  • BS or BA in Related Field and 3+ years of related Scientific or Quality Assurance Experience preferred.
  • Experience:
  • Proficient in Word, Excel and Sharepoint.
  • Must have demonstrated knowledge in regulations and guidance associated with cGMPs.
  • Possesses an understanding of regulatory compliance relating to pharmaceutical and biotech industries.

We will identify candidates based on the following:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits:

  • Join a high growth and fast paced organization with a people focused culture
  • Global exposure, defined career path and annual performance review and feedback process
  • Competitive benefits, 401K and paid time off

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