Regulatory Affairs Manager - United Kingdom
- Our company is one of the world’s largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 employees globally.
- For more than 35 years, our company has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient.
- our company has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
- Reporting to a Regional Group Leader, this role will support one or more products from a regional (extended Europe) regulatory perspective.
- The incumbent will ensure that our company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products; market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety.
Strategy and Execution
- Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within company's portfolio in compliance with global filing plans and local regulatory requirements.
- Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provides content guidance for regional regulatory documents and meetings in accordance with global strategy
- Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
- Supports regional label negotiation activities
- Under general supervision participate in the development, and execution of regional regulatory product strategies
- Obtains and maintains Clinical Trial Authorizations including Response to Questions
- Communicates regulatory strategies within team
- Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
- Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to company products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Under supervision evaluates 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 MA, post approval changes, extensions and renewals.
- Knowledge of drug development
- Knowledge of and experience in regional regulatory environment
- Team work
- 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
- MSc/PhD in Life Sciences
- Experience interacting with regulatory agencies
- Knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.