Senior Regulatory Affairs Associate

Proclinical is currently recruiting for a Senior Regulatory Affairs Associate job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid regulatory affairs experience their team at their offices in Uxbridge. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally. Senior Regulatory Affairs Associate, this role will focus on EU Clinical Trials within Oncology including Switzerland, CIS and Baltic regions.

Job 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
• Support process improvement initiatives, standards development, and metrics

Skills and Requirements:

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

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.