Expiry Date: 23-11-2022
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
My team and I would like to let you know about a fresh role we are working on with an exciting innovator headquartered in the UK, who is developing novel medicines with a unique mechanism of action, who are focused on treating high unmet medical needs for Oncology indications.
The pipeline is in early development and their NMEs are all based on their own technology and development platform. They have strong culture and company values, which means your dedication and determination will be rewarded because they work as one big team to deliver results and bring medicines to the patients.
The company is well-funded, and they are ramping up to become a (major) drug development company, and already have several collaborative partnerships with some leading major pharmaceutical organisations.
We are looking for an experienced Regulatory Affairs Manager or Senior Manager who wants to join the team, to take accountability for the development and execution of regulatory strategies for assigned projects and programs, including development and maintenance of the Regulatory Plan, maintenance of regulatory files and collaborating with external regulatory / quality consultants and external stakeholders to support regulatory submissions, and response to Health Authorities questions.
Excellent mentoring and training will be provided by the Cambridge based Head of Regulatory Affairs, who will guide and support you as you grow and develop your strategic expertise as the regulatory lead for your projects, staring in P1/P2 all the way through to MAA.
You will like this role if you enjoy managing the preparation, planning, risk mitigation and review of submissions for different programs and projects, which may include some strategic submissions like INDs, CTAs, PiPs and ODDs. As a strategist, you will monitor the regulatory landscape to anticipate changes that might affect your assigned projects and you may act as the Global / Regional Regulatory Lead for these assigned programs.
Our client would like to hire someone adventurous, communicative, and consensual, to develop and maintain internal cross-functional relationships to support the development and execution of regulatory strategies and bring results to the organization and their patients.
The role can be fully remote with occasional visits to the office upon business needs.
On offer is a competitive package including a good base salary for this grade, bonus and stock options and excellent holiday allowance.
To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or send a full CV to email@example.com. I will support you throughout the interview and on-boarding experience.
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