Regulatory Compliance Analyst

2 weeks ago

Somerset, New Jersey, United States IMS People Full time
Job Overview

Position: Regulatory Compliance Analyst

Location: Not specified
Duration: Not specified
Shift: Not specified

Role Summary:

The Regulatory Compliance Analyst is expected to possess extensive knowledge of international regulations relevant to the pharmaceutical sector and their implications on production methodologies. The ideal candidate should be adaptable, well-structured, and demonstrate exceptional interpersonal, compliance, and practical application abilities. This proactive, results-driven professional must be capable of gathering, analyzing, disseminating, and communicating data and its consequences at both local and organizational levels.

This position holds significant visibility within the organization, interacting with various departments including Supplier Quality, Regulatory Compliance, and Quality Management Systems. It is an integral part of the Clinical Development and Supply division.

Key Responsibilities:

  • Oversee the supplier quality program to ensure all Supplier Quality Management objectives are achieved.
  • Coordinate and conduct customer audits to confirm adherence to current Good Manufacturing Practices (cGMPs) and internal standard operating procedures.
  • Participate in corporate internal audits to validate compliance with FDA and global health authority regulations.
  • Lead preparations for inspections by regulatory bodies.
  • Manage the internal audit program.
  • Assist in drafting responses to audit findings and ensure timely follow-up.
  • Notify management of any unresolved audit issues.
  • Initiate corrective actions when standard procedures are not adhered to.
  • Prepare for audits related to new product approvals.
  • Contribute to the development of Supplier and Customer Quality Agreements.
  • Represent the organization in global supplier and regulatory discussions.
  • Review and authorize quality records.
  • Update departmental standard operating procedures as necessary.
  • Adhere to Environmental, Health & Safety regulations.
  • Perform additional duties as assigned.

Qualifications:

Education & Experience:

  • Bachelor's degree with a minimum of 5 years in Quality/Regulatory Compliance or related fields.
  • Associate degree or High School Diploma with 10+ years of relevant experience.

Knowledge Requirements:

  • Thorough understanding of FDA and cGMP regulations applicable to pharmaceutical manufacturing.
  • Familiarity with FDA regulatory standards for solid oral dosage forms or equivalent experience.
  • Comprehension of various audit types and methodologies.
  • Experience with TrackWise is preferred.
  • Certification in Quality Assurance is highly regarded.

Additional Information:

  • Start Time: Not specified
  • Hours: Not specified
  • High-risk Requisition: No
  • Background Check Required: Yes
  • Drug Test Required: Yes

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