PE Global are currently recruiting for a Regulatory Affairs Manager (CTA) with EU experience for an initial 12 month contract role with a leading multinational Pharma client based in either Uxbridge or Cambridge - 1 day per month in the office.
You will be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.
Job Responsibilities
• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within our portfolio in compliance with global filing plans and local regulatory requirements.
• Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
• Support regional label negotiation activities
• Under general supervision participate in the development, and execution of regional regulatory product strategies
• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to our products.
• Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Under supervision evaluate and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling.
Requirements
• EU experience
• Scientific Degree and demonstrated experience in a similar role
• Regulatory principles
o Working with policies, procedures and SOP’s
o Knowledge of legislation and regulations relating to medicinal products
o Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
• Knowledge of drug development
• Knowledge of and experience in regional regulatory environment
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and prevent potential issues
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Interested candidates should submit an up to date CV.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***