Sobre este puesto de Specialist, Regulatory Affairs Contractor en Biorasi, LLC
We are Growing! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization.
Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.
Your role:
- Prepare and coordinate preparation of submission specific documents for initial submissions und amendments
- Work independently on Ukrainian Regulatory submissions activities
- May coordinate translation of submission specific documents
- Coordination and execution of submissions and query responses to Regulatory Authorities and Ethics Committees / IRBs in the assigned regions, including safety related submissions
- Provide regulatory advice to project teams and key internal/external stakeholders for start-up and maintenance activities in the assigned clinical projects
- Ensure high quality of all regulatory documents
- Track all submissions and responses to / from competent authorities and Ethic Committees / IRBs in a timely manner
- Participate in internal and external teleconferences and project team meetings
- Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Participates in advocacy activities of a technical and/or tactical nature
- Provides training on national / regional legislation, country requirements to other project team members
- Prepares in cooperation with the PM the study specific regulatory plan
- Support the QA department to prepare for and during Audits and Inspections regarding regulatory related aspects
- Supports writing SOPs for the Regulatory Affairs department
- Support Legal/Contracting team to address regulatory issues
Your Profile:
- Bachelor’s Degree in biomedical sciences or related scientific discipline.
- Fluent English (oral and written) and local language.
- 5-8 years in drug development and/or regulatory affairs within the pharmaceutical or related industry.
- Experience in clinical trial process
- Solid expertise in clinical trial regulatory submissions in Ukraine
- Knowledge of guidance documents, regulatory legislation, various international regulatory requirements, and approval procedures in the assigned countries. Working knowledge of ICH/GCP principles.
If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at [email protected].
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
