Regulatory Affairs Manager

Bayer has two exciting career opportunities for UK Regulatory Affairs Managers within the Pharmaceutical Division based in our Reading offices. In these new roles you will provide regulatory strategic leadership and support for the Bayer portfolio. Level of seniority of the roles will be determined by knowledge and experience of the candidates.

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 our chosen therapy areas.

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.

Key Responsibilities

• As part of the UKI team, you will evaluate new assets representing UKI Regulatory in cross functional teams. This includes provision of information on the regulatory environment, shaping early development decisions and providing aligned regional input for strategic development decisions
• You will deliver innovative regulatory strategies and promote awareness of regulatory requirements.
• You will be able to produce high-quality marketing authorisation, variation and clinical trial applications in line with UK/EU requirements.
• You will manage regulatory challenges and pro-actively highlight the impact of external changes. Experience handling UK applications in the post Brexit environment is a real advantage.
• You will be keen to participate in external EU/UK committees/working groups and support team development by being an ambassador for the UKI Regulatory team.

Basic Qualifications

• Bachelors or advanced degree in an appropriate scientific discipline
• Experienced UK/ EU regulatory professional having managed major submissions and approvals with some knowledge of new MHRA regulatory pathways
• Sound knowledge of clinical trial requirements and experience with CRS
• 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.

Location:

United Kingdom: Berkshire: Reading

Hybrid working with minimum of 2 days per week in the Reading Office Occasional Travel may be required