The primary function of this role is to ensure that PAI regulatory obligations for products and facilities in both development and lifecycle management comply with the most current regulatory standards and that compliance risks are appropriately identified and mitigated.
Support Regulatory Affairs & Compliance oversight activities by:
- Maintaining status and oversight on Regulatory-related commitments
- Maintaining status oversight on Audit Observations & related CAPA status assigned to the RA/Compliance group
- Monitoring Regulatory/Compliance regulations and standards related to FDA expectations for pharmaceutical production, cGMP, DEA, USP-NF and Labeling for status and effectiveness o Analyzing production and product related data for trending, process analysis and product understanding
- Analyzing Audit/Inspection observations related to Regulatory/Compliance activities for trending and change control/CAPA related effectiveness.
- Support Regulatory Compliance and Quality Documentation Management:
- Coordinate creation and maintenance of Policies, Standard Operating Procedures and standards supporting the PAI and Regulatory Affairs/Compliance
- Support maintenance of and compliance to training plans.
Manage Regulatory-related Deviations & CAPA process for the GRA Practice:
- Manage/Support QMS process for Regulatory Affairs and Compliance, Facilitate Audit/Inspection-related activities impacting the organization
- Support Audit & Inspection-readiness activities
- Collaborate with Audit/Inspection Observations, responsible departments and related CAPA owners by providing support to facilitate timely resolution and closure.
- Provide Compliance expertise in initiatives and in projects:
- Participate in compliance/risk mitigation and process improvement initiatives in collaboration with cross-functional teams
- Build & maintain expertise, oversight & network through projects
- Share information within the organization to foster growth of Compliance in knowledge and practice
- Participate to workshops & organize meetings/trainings with stakeholders.
At least 8 years of relevant experience in the pharmaceutical industry, with a minimum of 4 years in Regulatory Affairs, Compliance and/or and Quality Assurance within the Pharmaceutical industry.
Regulatory audits and inspections experience is required. Experience working in a cGMP/manufacturing environment is required. Regulatory submissions writing/review experience is strongly preferred.
Knowledge and understanding of:
- Regulatory Affairs and Compliance Processes
- Pharmacovigilance obligations
- Quality Assurance
- Quality Management System
- Artwork management
- Supply Chain
- Understanding of Generic Pharmaceutical Business.
- Expertise in technology systems utilized for electronic documentation, including, but not limited to: Microsoft Office, Electronic Document Management System (EDMS)
- Expertise in technology systems utilized for the tracking of activities: Regulatory Tracking Database, BIBO environment, Trackwise or equivalent QMS systems
- Good presentation and training skills
- Good analytical and investigation skills
- Project management skills; excellent planning and organizational skills
- Technical writing for regulatory submissions
- Ability to prioritize based upon the compliance and patient safety risk
- Ability to identify critical issues and when they need to be escalated to senior management
- Accountable for the compliance of all activities in scope of responsibilities
- Strategic and results focused - ability to overcome obstacles and achieve key outcomes, ability to challenge the status quo in a constructive manner
- Integrity - overriding commitment to integrity and high standards in self and other