Regulatory Program Manager - Hertfordshire
Zest Scientific is partnered with a leading pharmaceutical organisation and we currently have an opportunity for a talented Regulatory Program Manager to join our client’s global, multi therapeutic group within Regulatory Program Management.
There is a competitive package including negotiable salary, generous car allowance and bonuses.
Responsibilities of the Regulatory Program Manager:
- Working independently, as well as within a regulatory sub-team, you will participate in and represent the regulatory function on cross-functional global teams in early and/or late stage projects. You will contribute to the global clinical drug development plan through a drug’s development and lifecycle. Specifically, you will be responsible and/or support the development and implementation of regulatory strategies in the EU and other key countries.
- You will be involved in Health Authorities interactions in these countries.
- You will coordinate and lead the preparation and submission of regulatory submissions e.g. core dossiers for CTAs, briefing packages for Scientific Advice and Qualification Advice and/or registration documents for MAA/variations, ensuring successful registration and acceptable labelling. You may also support registration activities in key countries outside of the EU.
- As the primary interface with Affiliate Regulatory Affairs, you will ensure Affiliates are informed of project developments and activities, enabling dialogue and their contribution in all relevant project/program developments and activities.
Who we are looking for:
- We are looking for a highly motivated and committed individual who has broad regulatory knowledge and the experience and ability to manage issues with meticulous efficiency.
- As a Regulatory Affairs professional, you should bring a very good level of experience in regulatory science and innovative clinical drug development, e.g. sound knowledge of EU legislation, guidelines and procedures, successful management of regulatory submissions and procedures, direct interaction with Health Authorities and strategic regulatory input in drug discovery and development, especially clinical aspects.
- We are looking for solid leadership competencies, so you should be an agile strategic thinker with articulate communication skills at all levels and the ability to work effectively both within a team environment and independently.
- You should be able to influence teams and functions in defining global development strategies.
- You should have a University or higher degree in a scientific or technical discipline. Ideally you will have experience within neuroscience/orphan disease Paediatric and Orphan drug development experience would be a plus.
- You will be fluent in both written and spoken English, with an awareness of working globally.
Contact: Neil Dewsbury
Telephone: 0114 238 1728