Regulatory CMC Compliance Consultant

This role is responsible for supporting the GRA Compliance department. Most of the time spent will be on the support of the CMC Compliance Project. The CMC Compliance Project is a significant effort undertaken by GRO and is transitioning from analysis and strategy setting to completion of the mitigation plans.

This role will interact with colleagues at all levels of management in the following functions/roles: CMC, Global and Site QA, Local Operating Company Regulatory Leads, Manufacturing and Testing Partners, Global Regulatory Leads,

The person in this role will work with and under the direction of GRA Compliance staff to assure completion of remediation activities and assure all gaps are closed or managed within the appropriate processes (Change Control, current or future Submissions).

Skill/Experience:

• CMC Experience (working knowledge of CTD Module 3; ability to assess that documents and responses received from SMEs are appropriate and complete to close gaps)
• Effectively collaboration and communication skills (will work with CMC Leads, LOC RA, Internal and external Site representative (manufacturing, testing, packaging, etc.), QA)
• Ability to schedule, prepare materials, and Lead effective meetings
• Tracking and follow up on actions and assure closure of gaps
• Experienced with end-to-end Change Control process
• Knowledge and experience in using various EDM systems
• Experience with Microsoft SharePoint (ability to create and administer preferred), Excel (Macro, Pivot Tables)

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

Reference ID: (BS: 1127)

Job Types: Full-time, Contract

Experience:

• CMC: 5 years (Required)
• Module 3: 3 years (Preferred)
• Change control: 3 years (Preferred)