Write, review, and assemble high-quality regulatory submissions, including but not limited to
- Preparation of IND and IMPD modules
- EMA/FDA Interactions and Correspondance
- Participate in the definition and implementation of regulatory strategies for the development of ATMPs
- Provide support for the preparation of Agency meetings (EU and US).
- Remain current with EU and US regulatory trends and requirements. Manage regulatory risks and potential based on global regulations and guidance.
- As a project team member, execute the prescribed activities, adhering to strategy, timelines, and milestones.
- Project coordination and keeping track of timelines/deliverables using project management tools.
- Timely internal and external communications and updates.
- Perform background research and coordinate scientific, technical, and regulatory surveillance to be performed related to the Project
The ideal candidate will possess the following qualifications
- Knowledge of Regulatory Sciences as demonstrated through a combination of work experience and academic background.
- Prior experience in pharma, biotech, or related life sciences industry
- Prior experience with regulatory submissions and interactions with the FDA and other regulatory agencies preferred
- Direct interactions with the Health Authorities is a plus
- Good understanding of the drug development process (ATMPs is a plus)
- BS/BA in Regulatory Affairs or Life Sciences. MS and Ph.D. are a plus.
- Strong attention-to-detail, organization/multitasking, project management (planning, scheduling, documentation, project control), teamwork, and communication (written and verbal) skills.
- Problem-solving abilities and a self-starter.
- Ability to work under deadlines to meet project timelines, including the ability to modify work schedule when needed.
- Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint), and Adobe Acrobat.
- Maintains company values (People, Innovation, Passion, Excellence) and demands the highest standards of conduct from self and others.
- A diversified full-time permanent position within a high-potential innovative biotech company.
- To work in a human-sized, dynamic, respectful and professional environment.
- The opportunity to take part in a challenging scientific and business growth.
- An attractive salary package in line with the position responsibilities and your experience.