LTO Regulatory Partner

Role

As a Regulatory Partner at Roche UK, you will be a vital part of our UK Regulatory Chapter. You will leverage your regulatory and scientific expertise to shape and drive strategic initiatives. This is your opportunity to make a difference and be part of a company dedicated to improving lives.

Responsibilities

UK Regulatory Group Responsibilities - The Regulatory group collaborates with the wider business to translate the constantly evolving requirements of the UK regulatory environment into Roche policies, procedures, solutions, and strategies that ensure compliance and maximize the value for patients. Our activities encompass:

• Clinical Trial Applications
• National Licensing Applications
• Early Access to Medicines Applications
• National components of medicines authorization via the European Centralized procedure

The team serves as Roche's primary contact with the MHRA, requiring effective cross functional collaboration at both local and global levels, as well as the capability to negotiate and influence externally.

Regulatory Partners need to be adaptable and entrepreneurial to identify opportunities, while maintaining a focused approach on ensuring compliance and playing a key role in retaining Roche UK's License to Operate.

Qualifications

Who You Are - You are a passionate regulatory expert with a clear vision for improving patient outcomes. With broad and comprehensive expertise within the UK regulatory environment, you will lead foundational work and partner with the business to solve complex regulatory issues impacting the chapter and/or wider business. You will contribute to the development of squad/chapter based strategic plans and goals, and actively participate in the learning and development of other chapter members. You will have the ability to understand scientific and technical information relating to an assigned portfolio of Roche products. You also bring:

• A Scientific University degree
• Extensive experience in UK Regulatory Affairs
• Proven experience managing UK submissions post Brexit
• Experience providing strategic and technical advice
• In depth knowledge and experience of UK and EU regulatory requirements and procedures
• A proven track record of developing, implementing, and communicating regulatory strategies
• Excellent documentation skills to ensure high quality and timely submissions
• Experience as a Subject Matter Expert (SME) in defined subject areas or therapeutic areas
• Experience in mentoring peers, as well as managing stakeholder relationships

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care.