Are you looking to develop your career and have access to varied and interesting work, then read on.
Woodley BioReg is experiencing exciting times and is looking for individual contributors with the purpose of contributing to regulatory and quality project teams and reviewing technical data and providing regulatory review and technical input.
About the company
Woodley BioReg provides high quality scientific advice and consulting services in Regulatory Affairs, Quality, and Project Management for all stages of product development, acting as the link between the global boards of health/regulatory agencies and healthcare product suppliers and manufacturers.
We help pharmaceutical, biopharmaceutical, healthcare, and medical device companies to develop and manufacture quality products that are effective and safe for patients worldwide. We are our clients’ CMC experts and are relied on as such.
Some of your key responsibilities will include:
- To contribute to regulatory and quality project teams
- To provide regulatory review and technical input
- To become point of contact in given specialism
- To learn and develop skills to prepare and contribute to regulatory documentation (e.g., relevant sections within CTAs, MAAs, INDs and NDAs, Variations, Renewals), etc.
- Regulatory documentation preparation (e.g., relevant sections within CTAs, MAAs, INDs, and NDAs)
- To engage with the wider team and sector to gain wider knowledge of the industry, changes in legislation and working procedures affecting the environment of Woodley BioReg
- Provide support to other functions with Woodley BioReg as requested
- To build and maintain expertise and develop a scientific profile in appropriate scientific disciplines, through publication and attendance at relevant scientific and regulatory meetings and/or conferences.
- To compile and review Marketing Authorisations (MAA, PLA, BLA, etc)
- To review technical data as part of a project team (sections m2, m3)
- To provide quality review and input particularly for CMC matters.
Medical Devices Specific
- To compile and reviews Technical Files / Design Files for medical devices and in vitro diagnostics
- To be able to operate to MDD and MDR requirements for all device Classes (and as a minimum for Class I and II devices)
- To provide regulatory strategy for the filing of MD and IVD application in GB and EU
- Regulatory documentation preparation (e.g. CE marking, UK CA, 510K)
You will be expected to work overtime and weekends when required and to attend domestic and international technical conferences/exhibits, circa 5%-10% of time. You will also need to develop an up-to-date knowledge of developing regulatory / registration requirements within the UK and EU.
You will have a BSc, or country equivalent, as a minimum, in a relevant life-science subject 5 – 10 years regulatory experience.
You will also need:
- BSc, or country equivalent, as a minimum, in a relevant life-science subject
- Ph.D. in a life sciences subject would be desirable for biopharmaceuticals applicants.
- Locally recognised professional Regulatory qualification, or working towards, e.g. TOPRA in UK
- 5-10+ years regulatory experience
- Experience of biologics and / or pharmaceutical industry
- Excellent organisational skills, attention to detail, interpersonal and communication skills (written and oral) are essential.
- Professionalism, being able to adapt to client situations and manage and deliver client expectations.
- Quality, to deliver work which is of a high standard.
- Productivity, be able to focus on delivery to achieve project objectives.
- Accuracy, ability to utilise technical ability and ensure attention to detail.
- Value adding activity.