about 2 months ago
Job title: Senior Regulatory Affairs Manager - Global Rare Disease
A growing Rare Disease Biotech based in Buckinghamshire are seeking a Senior Regulatory Affairs Manager. This is a global role focused on an initial three markets - Israel, Turkey and Switzerland. In this role you will work cross-functionally and with external partners to develop and execute regulatory strategies to gain approval and then maintain marketing authorisations. This role is office-based 1 day per week.
- Preparation and submission of high-quality regulatory applications in Eastern Europe, Middle East and African Markets, including preapproval applications (paediatric, Orphan Drug, scientific advice), marketing authorisations submissions.
- Effectively partner with other members of Global Regulatory Affairs, cross-functional stakeholders, and external partners to deliver the regulatory contribution of business goals and objectives for the region.
- Establish and maintain strong and effective relationships with Regulatory Agencies, CROs, and local partners.
- Contribute and lead initiatives to develop and implement process and system improvements to improve the efficiency of the Global Regulatory Affairs organisation.
- Bachelors or Master's Degree in a scientific discipline or equivalent is required
- Relevant level of regulatory experience respectively within the pharmaceutical or biotechnology industry.
- Experience in developing and executing creative regulatory strategies for rare diseases including marketing applications and post approval applications in Eastern Europe, Middle East and Africa, Asia, or Latin America is required. Experience in preparing regulatory applications and developing regulatory strategies for Europe and Switzerland is also beneficial.
- Must have a solid understanding of global regulations and ICH guidance, as well as comprehensive experience in the drug development process.
- Experience working in an external development business model in collaboration with strategic local partners and distributors.
Salary and benefits:
A highly competitive salary, annual bonus and equity is on offer with this role.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org