Amy Lloyd is recruiting for an opportunity for a Senior Regulatory Program Manager to join a global leader in research-focused healthcare.
My client has an opportunity for an exceptional Senior Regulatory Programme Manager to join their global I2ONE (immunology, infectious disease, ophthalmology, neurosciences and established products) group within Regulatory Programme Management, working primarily on neuroscience/orphan disease portfolio.
- 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.
- Contribute to the global clinical drug development plan through a drug's development and lifecycle.
- Lead interactions and negotiations with Health Authorities for drug development programmes and project issue management in these countries for CTAs, Scientific Advice and Qualification Advice and/or for MAA/variations.
- Be accountable for the development of key regulatory communications for Health Authorities and internal stakeholders for a programme.
- 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.
What they are looking for:
- Highly motivated and committed individual who has broad regulatory knowledge and the experience and ability to manage complex issues with meticulous efficiency.
- As a Regulatory Affairs professional, you should bring an excellent 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.
- Strong leadership competencies, so you should be an agile strategic thinker with exceptional 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 be able to coach and develop talent within the regulatory organization.
- You should have a University or higher degree in a scientific or technical discipline. Ideally you will have experience within neuroscience/orphan disease areas. Paediatric and Orphan drug development experience would be a plus.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46851 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Amy Lloyd
- Phone: 01438 743047
- Reference: 46851
- Posted: 23rd October 2019
- Expires: 20th November 2019