Job Title: Regulatory Submissions Manager
Full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
- Efficiently manage and successfully execute all aspects of global start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits.
- At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Knowledge and experience of Clinical Trial Applications within Europe;
- Strong oral and written communication skills;
- Team oriented approach and strong leadership skills; and
- Fluency in English.
- Agency: Achieva Group Limited
- Reference: BH-34278
Website: Achieva Group Limited
- Posted: 25th January 2023
- Expires: 22nd February 2023