Principal Consultant - Regulatory Compliance (C&GT and/or Biologics)

Parexel’s Regulatory Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Regulatory Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing!

We currently have a home-based opening on our Regulatory Compliance Team for a highly experienced Cellular and Gene Therapy / Biologics Compliance Expert to join the Parexel Regulatory Consulting team as Principal Consultant.

A Principal Consultant will have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with cGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients at all levels within their organization.

A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. A Principal Consultant provides a full range of consulting services and works within their personal area of expertise. A Principal Consultant provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC.

We are currently seeking experts with past experience helping pharmaceutical and biopharmaceutical companies to manage and prepare for FDA inspections and to manage post inspection activities.

To include specialized experience in the following:

• Implementation of compliant Quality Systems
• Audits:
  • Sponsor-Monitor Audits (Drugs and Biologics)
  • Clinical Investigator Audits (Drugs and Biologics)
  • CRO Audits (Drugs and Biologics)
  • Drug and Biologic GMP Audits
  • Data Integrity Assessments
• Assist in the preparation of written responses and remediation plans to address FDA-483 Inspectional Observations and Warning Letters
• On-Site guidance during FDA inspections
• Review of study protocols and recordkeeping documents for clinical site use
• Preparation for Discussion of Regulatory Compliance Matters with FDA
• Compliance Remediation strategy and implementation

Qualifications

Education:
-PhD in a in a scientific discipline or other advanced degree or equivalent in engineering with 12-15 years of experience; may include post doctoral experience, preferred.

Knowledge and Experience:
- Reputation as emerging leader in field with sustained performance and accomplishment
- Expertise and experience in cellular and gene therapy, and emerging markets and regulatory expectations and for the US, EU and APAC markets, is a plus
- Previous Industry experience in Quality and/or Compliance or previous experience as a Consumer Safety Officer, BIMO and/or Compliance Investigator, or similar role to include numerous years’ experience planning and conducting complex regulatory inspections and in-depth investigations coupled with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) are required.
-Expert knowledge of scientific principles and concepts.

Skills:
-High-level consulting skills
-Critical thinking and problem-solving skills
-Project leadership and management knowledge
-Excellent interpersonal and intercultural communication skills, both written and verbal
-Client-focused approach to work
-Results orientation
-Teamwork and collaboration skills
-Proficiency in local language and extensive working knowledge of the English language
-Account planning and support
-Networking
-Business acumen and analysis
-Self-confidence and control

Up to 70% Domestic and International Travel Required

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.