The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Main Responsibilities of the role:

• Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
• Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
• Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
• Review regional component of the Global Regulatory Plan and provide input to operational deliverables
• Ensure compliance via timely submissions to regulatory agencies
• Support RRL in review of promotional materials for commercial activities (ex-US) Collaborate with CROs / partners to support site initiation
• Coordinate collection of functional documents in support of regulatory applications
• As appropriate participate in GRT to support execution of regulatory strategy
• Coordinate QC of regulatory documentation (e.g. briefing packages)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
• Prepare regulatory packages and cross-reference letters to support investigator initiated studies
• Approve drug shipment for the company and Investigator
• Initiated Studies Complete regulatory forms to support agency communications (E.G. EudraCT,)
• Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
• Support process improvement initiatives, standards development, and metrics
• Assist in template development and maintenance
• Respond to specific requests from and communicate relevant issues to GRT
• Develop Regulatory Position with teams
• Actively support regulatory compliance
• Support the development and execution of GRT goals

Key Skills

• Strong communication skills - oral and written
• Organizational skills
• Understanding of drug development process

To apply for this and similar roles please send your CV to queries@peglobal.net.