Regulatory Lead UK & Access Consortia - Rare Disease - UK
SciPro are currently partnering exclusively with BridgeBio for the recruitment of their Regulatory Lead for the UK and Access Consortia. BridgeBio is focused on translating today's discoveries into tomorrow's medicines and is dedicated to deliver breakthrough medicines for genetic diseases.
Currently with a portfolio of 20 drugs with 3 already approved in the US across genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease and ophthalmology, it offers an amazing opportunity to be able to join a company with incredible prospects for its employees.
We are looking for an experienced regulatory leader to lead on the development and execution of European regulatory strategy and to be responsible for key product projects for the UK and countries in the Access Consortia, Australia, Switzerland, Canada and Singapore.
The role will include:
Liaise primarily with members of Clinical, CMC, Commercial, Medical Affairs, Quality, and Regulatory Affairs to develop and execute European Regulatory strategies aligned with business objectives.
Provide guidance, direction, and leadership on those strategies to development teams and executive management.
Represent European Regulatory Affairs in cross-functional development teams for assigned products
Build a regulatory team to support current and future portfolio.
Provide strategic input to planned commercial campaigns to meet business objectives while ensuring regulatory compliance
University Degree in Science or related discipline. A higher degree would be desirable, especially one specific to regulatory affairs.
Extensive knowledge and experience of working in one or more areas in regulatory affairs in the pharmaceutical industry or experience with a health authority for 10-15 years
Ideally a combined mix of large company and small biotech.
Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people
Pre-and post-product launch experience in key European markets
What They Offer:
Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
Learning and development training to help employees be the best version of themselves
Collaborative business environment
Excellent compensation package and benefits package
A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
Work with the most productive groups of R&D operators in the industry
Partnerships with leading institutions
A platform for meaningful scientific contributions to shine
Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
The position is remote and offers a competitive salary and benefits package. If you are interested in applying then please send through a copy of your CV!