Regulatory Affairs Manager
Uxbridge or Cambridge
£55,000-£60,000 plus LTIs, car allowance, bonus, pension, healthcare
My client are seeking a Regulatory Manager to join them in either the General Medicine or Oncology Regulatory team, part of the Global Regulatory Affairs function in Europe. This team 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.
To acquire and maintain all the required licenses to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
You will support one or more products from a regional regulatory perspective, within either Oncology or General Medicine, depending on your expertise and interest.
Strategy and Execution
· Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within the 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
· 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, guidances, current regulatory environment and competitor labelling
· Scientific Degree and demonstrated experience in a similar role
· Regulatory principles
· Working with policies, procedures and SOP’s
· Knowledge of legislation and regulations relating to medicinal products
· 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
This role will be majority work-from-home, with weekly trips to the Uxbridge or Cambridge offices required.
In return for your work, my client offer growth opportunities to learn and move up in a global organization, working in a diverse and inclusive community of belonging. They offer a generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.
If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.
- Business Development Manager
Job location: Reading, Reading, England Job salary: £Salary Range : £70 – 85,000 PA + Benefits
My client is a Reading-based growing biotechn...
- Statistical Analyst I
Job location: Job salary: £Salary- $107,000-140,000
RBW is partnered with a full-service CRO look...
- Senior Biostatistician
Job location: Job salary: £Salary- $160,000-210,000
Looking for a change? We are partnered with a...