Braze is looking for a Regulatory Manager / Senior Regulatory Manager (Clinical Trials) to join our team. This role provides regulatory strategy and development guidance for the optimal conduct of clinical trials, ensuring the timely preparation of quality submissions. You will coordinate and prepare regulatory documents for submission to Regulatory Authorities and Ethics Committees.
What You'll Do
- Provide regulatory guidance throughout the clinical development life cycle.
- Compile, coordinate, and review applications to Regulatory Authorities including CTA/IND, annual reports, amendments, scientific advice meetings, orphan designations, paediatric planning, and marketing applications.
- Develop and/or review documents intended for submission to Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
- Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers.
- Work within a project team, and where necessary, lead projects for the region or globally.
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.
- Maintain project plans, project trackers, and regulatory intelligence tools as it pertains to assigned responsibilities.
- Assist in the development of Regulatory Affairs Specialists and other operational area staff.
- Provide input into regulatory strategy and timeline development for new study opportunities.
- Assist in establishing company standards to ensure the highest quality of submitted information.
- Participate in maintaining and executing on corporate quality initiatives across business units within clinical solutions.
- Keep abreast and continually expand knowledge of laws, regulations, and guidelines governing drug development and approval.
- Provide ICH GCP guidance, advice, and training to internal and external clients.
- Serve as representative of Global Regulatory Affairs at business development meetings.
What We're Looking For
- Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
- 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level.
- Computer literacy (MS Office/ Office 365).
- Fluent in English.
- Regulatory affairs experience working for a Clinical Research Organisation and experience leading Clinical Submissions.
- Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US).
- Ability to understand clinical and pre-clinical study results to help in its interpretation for regulatory positions and strategy.
- Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.
- Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.
- Availability for domestic and international travel including overnight stays.
Nice to Have
- Graduate or postgraduate degree.
- Basic understanding of financial management.
Technical Stack
- MS Office / Office 365
Team & Environment
You will work within a project team, and where necessary, lead projects for the region or globally. The role involves overseeing Regulatory Affairs Specialists.
Work Mode
This is a global role open to candidates in the UK, Spain, Hungary, Slovakia, Serbia, Romania, and Poland.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
