Bayer has an exciting new career opportunity for a Senior Regulatory Project Manager within the Pharmaceutical Division based in our Reading offices. In this new role you will provide regulatory strategic leadership and support for our Oncology portfolio and will be part of the Regulatory Policy and Intelligence Network concentrating on Europe.
Bayer is a global Life Science Company concentrating on the Healthcare and Nutrition sectors, with a vision for the future that promises health for all and hunger for none. In the Pharmaceutical Division, Bayer is committed to innovative scientific research and discovery, and guided by our purpose of Science for a Better Life, aim to improve patient’s lives by giving science meaning, and translating our research into solutions that make their lives better. As part of our commitment to serving patients, we aspire to become leaders within the Oncology field, and through our policy work to ensure Europe remains at the forefront of innovation.
We operate in a strong global network building on our business acumen, analytical skills and regulatory knowledge to advise our internal partners and negotiate with external stakeholders.
- Producing high-quality marketing authorisation, variation and clinical trial applications in line with UK/EU requirements.
- Delivering innovative regulatory strategies and promoting awareness of regulatory requirements.
- Managing regulatory challenges and pro-actively highlighting impact of external changes
- Contributing to UK / EU Regulatory Policy by assessing the external regulatory environment and communicating it to the internal organisation.
- Participating in external EU/UK committees/working groups.
- Supporting UK Regulatory team development by being an ambassador for the UK team.
- Bachelors or advanced degree in appropriate scientific discipline
- Experienced UK / EU regulatory professional having managed major submissions and approvals via the Centralised Procedure, preferably in oncology
- Sound knowledge of clinical trial requirements, particularly in major EU countries
- Ability to think strategically, sound commercial awareness and good knowledge of medicines development within EU
- Excellent communication skills including proven ability to influence by persuasion and negotiation. Ability to communicate complex information in an engaging manner, both verbally and in written form. Presentation skills are a key communication vehicle for networking within and outside the organisation.
- Ability to thrive in and foster strong matrix team working in a global environment