Description

The Senior Scientist, Regulatory Compliance will provide oversight of regulatory compliance activities to develop and implement regulatory strategies to ensure compliance with regulatory standards and client expectations with regulatory filings.

• Provide guidance and input to project teams on regulatory requirements related to document submissions in support of client regulatory filings.
• Provide regulatory feedback on new and existing raw material, in-process and product specifications and test methods.
• Provide feedback and/or lead project and site risk assessments relative to quality management systems and impact to client projects/regulatory filings.
• Obtain, maintain, and manage site registration and accreditation.
• Ensure the site is prepared for future challenges and regulatory changes by staying informed about industry trends and advancements.
• Serve as key regulatory contact for significant issues and work with cross-functional teams to resolve them.
• Manage and carry out product quality review and continued process verification programs. Compile data from paper and electronic sources to complete reports.
• Assist with quality records
• Including submission of CAPA plans, Change Requests, and Deviations in coordination with the Associate Director, Quality Assurance
• Author and Revise Quality Documents where applicable: SOPs and Policies
• Assist in preparation and participate in Regulatory Inspections or Corporate/Client Audits when necessary

BS, MS or Ph.D. in Chemistry (or closely related discipline). A minimum of at least 3 years of relevant background/leadership in GXP/QA/regulatory compliant pharmaceutical laboratory environment or Quality Assurance/Regulatory Affairs role (prefer late phase/commercial experience). Knowledge of GMP manufacturing and analytical techniques to support QA and Regulatory process. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant.

PI280203215