Senior Associate Regulatory Affairs

Senior Associate Regulatory Affairs required for a 12-month contract with a leading multinational client based in Uxbridge and Cambridge. 

The role

Remote work during Covid but the candidate must be within commute distance from Uxbridge or Cambridge. 

The Regulatory Affairs Senior Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects.

Responsibilities

• Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission).
• Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead.
• Coordinate collection of functional documents in support of regulatory applications.
• Prepare regulatory packages and cross-reference letters to support investigator sponsored studies.
• Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies.
• Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications.
• As appropriate may participate in GRT to support execution of regulatory strategy.
• Respond to specific requests from and communicate relevant issues to GRT.
• Support the development and execution of GRT goals.
• Review regional component of the Global Regulatory Plan and provide input to operational deliverables.
• May support RRL in review of promotional materials for commercial activities.
• Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams.

Requirements

• Experience working in the pharmaceutical industry.
• Strong communication skills – oral and written.
• Organizational skills.
• Understanding of drug development process.
• Experience working within an oncology department.
• Experience in regulatory documentation.

Interested candidates should submit an updated CV

Please click the link below to apply, call Alba on +44 2039 669 800 or alternatively send an up to date CV alba@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***